GEM Premier 7000 with iQM3 Recall Issued
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Instrumentation Laboratory is recalling 32 units of the GEM Premier 7000 with iQM3 due to incorrect active ingredient concentration in the lysing bag solution.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Instrumentation Laboratory initiated a voluntary recall of the GEM Premier 7000 with iQM3 after determining that the active ingredient concentration in the lysing bag solution of specific 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 Products Are Affected
The recall affects 32 units of the GEM Premier 7000 with iQM3 distributed worldwide, including US nationwide distribution in AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, and Italy.
Affected part numbers and lots:
- 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 260505A
- Part No. 00077415010, UDI-DI 00195226000658, Lot 260505C
- Part No. 00077430010, UDI-DI 00195226000641, Lot 260505B
Recall number: Z-2899-2026. Classification: Class II. Recall initiation date: May 21, 2026.
What You Should Do
Consumers and healthcare facilities should follow instructions provided in the firm's notification letter regarding the affected units.
Why This Matters
The device is used by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of care and in central laboratories.
Source
FDA recall event ID 99128. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,592 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.