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Moderate riskFDA DeviceClass II

GEM Premier 7000 PAKs recalled for off-spec solution

The active ingredient concentration in the lysing bag solution of certain GEM Premier 7000 with iQM3 PAK lots did not meet manufacturing specifications. This could delay recognition and management of co-oximetry and total bilirubin abnormalities and their consequences. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Instrumentation Laboratory recalls

What to do

  1. Set aside PAK lots 260504E, 260505A, 260505B and 260505C and do not use them, if they match the list below.
  2. Check part numbers and lots: 00077407508 (lot 260504E), 00077407510 (lot 260505B), 00077415004 (lot 260505A), 00077415008 (lot 260505A), 00077415010 (lot 260505C), 00077430010 (lot 260505B).
  3. Contact Instrumentation Laboratory about the affected PAKs. The notice doesn't say how to get a replacement or refund.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 2 products — see all of them.

Details

Units affected
32 units
Illnesses reported
None reported
Manufactured in
180 Hartwell Rd, Bedford, MA, United States
Classification
Class II
Recall number
Z-2899-2026

In the FDA's words

Description
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. 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. 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 Distribution: 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. Affected quantity: 32 units
Hazard
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.

2 products in this recall

GEM Premier 7000, 5000 PAK recalled for solution concentration

Instrumentation Laboratory is recalling 141 units of two blood analysis systems: 32 GEM Premier 7000 with iQM3 units and 109 GEM Premier 5000 PAK units. The active ingredient concentration in the lysing bag solution did not meet manufacturing specifications, which could delay recognition and management of co-oximetry and total bilirubin abnormalities. The FDA classified it as Class II, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

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