GEM Premier 5000/7000 Bar Code Reader Wand
Instrumentation Laboratory recalls BCR Wand for GEM Premier 5000/7000 analyzers; may assign results to wrong patient ID.
Stop using the affected Bar Code Reader (BCR) Wand immediately. Contact Instrumentation Laboratory for instructions on receiving a corrected configuration update or replacement wand. Do not use the wand to scan patient samples until the issue is resolved.
Why it was recalled
Instrumentation Laboratory is recalling the Bar Code Reader (BCR) Wand accessory for GEM Premier 5000 and GEM Premier 7000 blood analyzer systems. BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID due to a race condition, potentially leading to inappropriate clinical management.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Recall # | UDI-DI | Model/Catalog number |
|---|---|---|---|
| GEM Premier 5000 | Z-2825-2026 | 00024019255, 08426950870227, 25028719, 18021546, 18021549, 26012036, 18051850, 23054764, 21068342, 25080219, 26010781, 25122012, 25041639, 25120558, 25079944, 25079943, 25028719, 25100485, 25079947, 25100483 | 00024019255 Portable blood analyzer system |
| GEM Premier 5000 | Z-2823-2026 | 00024019255, 08426950870227, 20106073, 20106039, 19052933, 20116415, 20064792, 22062065, 22062067, 19103490, 22092716, 22102881, 18112339, 19012518, 20126582, 20075256, 20064794, 20106036, 24016057, 21088758 | 00024019255 portable blood analyzer system |
| GEM Premier 5000 | Z-2824-2026 | 00024019255, 08426950870227, 25110547, 25100462, 25110522, 25100472, 25101897, 25101920, 25101931, 25122029, 26012032, 25122030, 26012033, 26012043, 25110523, 25110536, 25120550, 25069638, 23101109, 24011137 | 00024019255 portable blood analyzer system |
| GEM Premier 7000 with iQM3 | Z-2822-2026 | 00000015279, 0195226000924, 26012062, 26012065, 26012069, 26012070, 00024015859, 08426950869634 | 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer |
| 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 | Z-2821-2026 | 00024019255, 08426950870227, 00000015279, 0195226000924, 00024015859, 08426950869634 | – |
| GEM Premier 5000 | Z-2826-2026 | 00024019255, 08426950870227, 25100466, 24097933, 23064897, 00024015859, 08426950869634 | 00024019255 Portable blood analyzer system |
| GEM Premier 5000 | – | – | 00024019255 |
| GEM Premier 7000 with iQM3 | – | 0195226000924, 7000, 08426950869634 | 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer |
| 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 | – | 08426950870227, 7000, 0195226000924, 2026, 08426950869634 | – |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Other recent recalls from Instrumentation Laboratory
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification