MEDICAL DEVICE RECALLMODERATE

GEM Premier 7000 with iQM3

Instrumentation Laboratory recalls GEM Premier 7000 with iQM3 due to lysing bag solution concentration issue.

What to do

Health care professionals should immediately check whether their GEM Premier 7000 with iQM3 system uses affected PAK lots and discontinue use of those lots. Contact Instrumentation Laboratory for instructions on returning affected product and obtaining replacement.

Recalled

2026-05-21

Listed

2026-08-06

Updated

2026-09-03

Recall No.

Z-2899-2026

Agency

FDA

Firm

Instrumentation Laboratory

Recall ID

99128

Status

ONGOING

Why it was recalled

Instrumentation Laboratory is recalling the GEM Premier 7000 with iQM3, a portable critical care system, because the active ingredient concentration in the lysing bag solution of specific PAK lots did not meet manufacturing specifications. This malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.

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	Lot code	Recall #	UDI-DI
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A	260505K, 260504AG, 260505F, 260505J, 260505R, 260505H, 260504AA, 260504AF	Z-2900-2026	00055360010, 08426950807599, 00055360011, 08426950807605, 00055407504, 08426950807537, 00055415010, 08426950807698, 00055430010, 08426950807759, 00055430011, 08426950807766, 00055445010, 08426950807810, 00055445011, 08426950807827, 00055360010, 08426950807599
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The	260504E, 260505B, 260505A, 260505C	Z-2899-2026	00077407508, 00195226000764, 00077407510, 00195226000665, 00077415004, 00195226000856, 00077415008, 00195226000757, 00077415010, 00195226000658, 00077430010, 00195226000641

Where it was sold

Distributed nationwide.

Timeline

2026-05-21Firm initiated recall
2026-08-06Publicly announced
2026-08-07Listed on Recall Canary
2026-09-03Summary updated

Official source

View on U.S. Food and Drug Administration →

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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