CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report
The GEM Premier 7000 with iQM3 is a portable critical care recalled
Instrumentation Laboratory is recalling The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care, distributed nationwide in the US. The recall was initiated on 21 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-2899-2026
- FDA event ID
- 99128
- Recalling firm
- Instrumentation Laboratory, Bedford, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 May 2026
- FDA classified
- 6 Aug 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 21 May 2026 | Recall initiated by company | |
| 6 Aug 2026 | Classified by FDA | +77 days |
| 12 Aug 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.
Where it was distributed
Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy.
Nationwide ArizonaCaliforniaFloridaGeorgiaIllinoisIndianaKentuckyMinnesotaMissouriMontanaOhioPennsylvaniaVirginiaWisconsinWest Virginia
Questions about this recall
Why was it recalled?
The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
Which lots are affected?
Part No.00077407508 UDI-DI 00195226000764 Lot 260504E; Part No. 00077407510 UDI-DI 00195226000665 Lot 260505B; Part No. 00077415004 UDI-DI 00195226000856 Lot 260505A; Part No. 00077415008 UDI-DI 00195226000757 Lot No.260505A; Part No. 00077415010 UDI-DI 00195226000658 Lot 260505C; Part No. 00077430010 UDI-DI 00195226000641 Lot 260505B
Where was it sold?
Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy.
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
1 other product · FDA event 99128This product is part of a recall event; the main page for the event is GEM Premier 5000 PAK Part Numbers recalled by Instrumentation Laboratory.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | GEM Premier 5000 PAK Part Numbers recalled by Instrumentation Laboratory | Instrumentation Laboratory | Device Malfunction | Nationwide |
More recalls from Instrumentation Laboratory
All 77| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 5000 with IQM2 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 |
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