GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 0
FDA device recall Z-2900-2026 · posted 2026-08-06 · Open, Classified
Recall details
- Recalling firm
- Instrumentation Laboratory
- Reason for recall
- The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- CHL
- Quantity affected
- 109 units
- 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.
- Date initiated
- 2026-05-21
- Date posted
- 2026-08-06
- Location
- Bedford, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEM Premier 5000 (K203790) | Instrumentation Laboratory CO | 2021-08-20 |