Skip to content

GEM Premier 7000 with iQM3 recallZ-2899-2026 · Instrumentation Laboratory · initiated May 21, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Instrumentation Laboratory or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On 5/21/26, the firm began notifying consignees in the US via letter. Consignees were informed that Werfen will be proactively shipping replacement PAKs to each facility. Customers were instructed to check inventory for affected product. They should discontinue use of the affected lots and destroy any inventory on hand. Destruction should be documented via the response form provided to the customer and returned to the recalling firm. Customers should forward the notification to all affected locations at each facility. On May 28, 2026, the field action was expanded to include affected customers in China. On June 23, 2026, the field action was expanded to include additional affected lots in Italy and Germany.

Recall details

Recall number
Z-2899-2026
Status
Open, Classified
Initiated by the company
May 21, 2026
Posted by the FDA
Aug 6, 2026
Recalling firm
Instrumentation Laboratory
Quantity
32 units
Product code
CHL
FDA submissions
K223608
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.

Product 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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K223608 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99128).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page