Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
- Agency
- FDA Device
- Recall date
- May 8, 2026
- Status
- Ongoing
- Company
- Instrumentation Laboratory
1. What product was recalled?
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Quantity: 21
Code or lot text: GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Spain: GEM Premier 5000 Serial Nos.: 25028719, 18021546, 18021549, 26012036, 18051850, 23054764, 21068342, 25080219, 26010781, 25122012, 25041639, 25120558, 25079944, 25079943, 25028719, 25100485, 25079947, 25100483, 25100484, 21057870 and 26010710. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634
- LOT
- 18021546
- LOT
- 18021549
- LOT
- 18051850
- LOT
- 21057870 and 26010710. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859
- LOT
- 21068342
- LOT
- 23054764
- LOT
- 25028719
- LOT
- 25041639
- LOT
- 25079943
- LOT
- 25079944
- LOT
- 25079947
- LOT
- 25080219
- LOT
- 25100483
- LOT
- 25100484
- LOT
- 25100485
- LOT
- 25120558
- LOT
- 25122012
- LOT
- 26010781
- LOT
- 26012036
- LOT
- GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Spain: GEM Premier 5000 Serial Nos.: 25028719
- LOT
- UDI No. 08426950869634
- RECALL-NUMBER
- Z-2825-2026
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Quantity: 3
Code or lot text: GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Argentina: GEM Premier 5000 Serial Nos.: 25100466, 24097933 and 23064897. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634
- LOT
- 24097933 and 23064897. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859
- LOT
- GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Argentina: GEM Premier 5000 Serial Nos.: 25100466
- LOT
- UDI No. 08426950869634
- RECALL-NUMBER
- Z-2826-2026
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Quantity: 27
Code or lot text: GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Hong Kong: GEM Premier 5000 Serial Nos.: 20106073, 20106039, 19052933, 20116415, 20064792, 22062065, 22062067, 19103490, 22092716, 22102881, 18112339, 19012518, 20126582, 20075256, 20064794, 20106036, 24016057, 21088758, 21088759, 18061910, 24016081, 24016108, 24108036, 24108044, 24067370, 24067371 and 24077468. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634
- LOT
- 18061910
- LOT
- 18112339
- LOT
- 19012518
- LOT
- 19052933
- LOT
- 19103490
- LOT
- 20064792
- LOT
- 20064794
- LOT
- 20075256
- LOT
- 20106036
- LOT
- 20106039
- LOT
- 20116415
- LOT
- 20126582
- LOT
- 21088758
- LOT
- 21088759
- LOT
- 22062065
- LOT
- 22062067
- LOT
- 22092716
- LOT
- 22102881
- LOT
- 24016057
- LOT
- 24016081
- LOT
- 24016108
- LOT
- 24067370
- LOT
- 24067371 and 24077468. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859
- LOT
- 24108036
- LOT
- 24108044
- LOT
- GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Hong Kong: GEM Premier 5000 Serial Nos.: 20106073
- LOT
- UDI No. 08426950869634
- RECALL-NUMBER
- Z-2823-2026
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Quantity: 67
Code or lot text: GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in United Kingdom: GEM Premier 5000 Serial Nos.: 25110547, 25100462, 25110522, 25100472, 25101897, 25101920, 25101931, 25122029, 26012032, 25122030, 26012033, 26012043, 25110523, 25110536, 25120550, 25069638, 23101109, 24011137, 25081799, 25081797, 25091839, 25091840, 25091864, 25091870, 25091868, 25091873, 25091880, 25091876, 25101886, 25101889, 25101887, 25101891, 25101907, 25101904, 25101912, 25101905, 25101917, 25101921, 25101926, 25101929, 25101934, 25101927, 25111968, 25121986, 25121985, 25121981, 25121984, 25121994, 25121995, 25121982, 25121993, 25121991, 25121999, 25121996, 16030255, 17060782, 17060784, 17060785, 17060789, 17060790, 17060797, 17111126, 17121258, 18011414, 20054515, 20054516 and 22082271. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634
- LOT
- 16030255
- LOT
- 17060782
- LOT
- 17060784
- LOT
- 17060785
- LOT
- 17060789
- LOT
- 17060790
- LOT
- 17060797
- LOT
- 17111126
- LOT
- 17121258
- LOT
- 18011414
- LOT
- 20054515
- LOT
- 20054516 and 22082271. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859
- LOT
- 23101109
- LOT
- 24011137
- LOT
- 25069638
- LOT
- 25081797
- LOT
- 25081799
- LOT
- 25091839
- LOT
- 25091840
- LOT
- 25091864
- LOT
- 25091868
- LOT
- 25091870
- LOT
- 25091873
- LOT
- 25091876
- LOT
- 25091880
- LOT
- 25100462
- LOT
- 25100472
- LOT
- 25101886
- LOT
- 25101887
- LOT
- 25101889
- LOT
- 25101891
- LOT
- 25101897
- LOT
- 25101904
- LOT
- 25101905
- LOT
- 25101907
- LOT
- 25101912
- LOT
- 25101917
- LOT
- 25101920
- LOT
- 25101921
- LOT
- 25101926
- LOT
- 25101927
- LOT
- 25101929
- LOT
- 25101931
- LOT
- 25101934
- LOT
- 25110522
- LOT
- 25110523
- LOT
- 25110536
- LOT
- 25111968
- LOT
- 25120550
- LOT
- 25121981
- LOT
- 25121982
- LOT
- 25121984
- LOT
- 25121985
- LOT
- 25121986
- LOT
- 25121991
- LOT
- 25121993
- LOT
- 25121994
- LOT
- 25121995
- LOT
- 25121996
- LOT
- 25121999
- LOT
- 25122029
- LOT
- 25122030
- LOT
- 26012032
- LOT
- 26012033
- LOT
- 26012043
- LOT
- GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in United Kingdom: GEM Premier 5000 Serial Nos.: 25110547
- LOT
- UDI No. 08426950869634
- RECALL-NUMBER
- Z-2824-2026
Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality con
Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer
Quantity: 4 US
Code or lot text: GEM Premier 7000: Part number: 00000015279 UDI: 0195226000924 Units distributed in US: GEM Premier 7000 Serial Nos. 26012062, 26012065, 26012069 and 26012070. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634
- LOT
- 26012065
- LOT
- 26012069 and 26012070. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859
- LOT
- GEM Premier 7000: Part number: 00000015279 UDI: 0195226000924 Units distributed in US: GEM Premier 7000 Serial Nos. 26012062
- LOT
- UDI No. 08426950869634
- RECALL-NUMBER
- Z-2822-2026
GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system
GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system. Affected Accessory: Bar Code Reader (BCR) Wand Part No. 00024015859
Quantity: 122
Code or lot text: GEM Premier 5000 Part number: 00024019255, UDI: 08426950870227 GEM Premier 7000 Part number: 00000015279, UDI: 0195226000924 Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634
- LOT
- GEM Premier 5000 Part number: 00024019255
- LOT
- UDI No. 08426950869634
- LOT
- UDI: 0195226000924 Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859
- LOT
- UDI: 08426950870227 GEM Premier 7000 Part number: 00000015279
- RECALL-NUMBER
- Z-2821-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Device source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.