CLASS II ONGOING Device recall · Reported 5 Aug 2026 · FDA Enforcement Report
GEM Premier 5000 with IQM2 recalled by Instrumentation Laboratory
Instrumentation Laboratory is recalling GEM Premier 5000 with IQM2, distributed nationwide in the US. The recall was initiated on 8 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2821-2026
- FDA event ID
- 99115
- Recalling firm
- Instrumentation Laboratory, Bedford, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 May 2026
- FDA classified
- 29 Jul 2026
- Reported
- 5 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 8 May 2026 | Recall initiated by company | |
| 29 Jul 2026 | Classified by FDA | +82 days |
| 5 Aug 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 99115This product is part of a recall event; the main page for the event is GEM Premier recalled by Instrumentation Laboratory.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | GEM Premier recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide | |
| CLASS II | GEM Premier recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide | |
| CLASS II | GEM Premier recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide | |
| CLASS II | GEM Premier 7000 with iQM3 recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide | |
| CLASS II | GEM Premier recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide |
More recalls from Instrumentation Laboratory
All 77| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The GEM Premier 7000 with iQM3 is a portable critical care recalled | Instrumentation Laboratory | Device Malfunction | Nationwide |
| Device | CLASS II | GEM Premier 5000 PAK Part Numbers recalled by Instrumentation Laboratory | Instrumentation Laboratory | Device Malfunction | Nationwide |
| Device | CLASS II | GEM Premier recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide |
| Device | CLASS II | GEM Premier 7000 with iQM3 recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide |
| Device | CLASS II | GEM Premier recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,663| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |