FDA Device recall Z-2821-2026
GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable bloo…
- FDA Device
- Class II
- ongoing
- Published 2026-08-05
On 2026-08-05 the FDA classified a Class II recall of GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable bloo… by Instrumentation Laboratory, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2821-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-08 |
| Published | 2026-08-05 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Instrumentation Laboratory |
| Distribution | US |
Product
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
Reason
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.
Identifiers
| code_info | GEM Premier 5000 Part number: 00024019255, UDI: 08426950870227 GEM Premier 7000 Part number: 00000015279, UDI: 019522…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2821-2026%22
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