Z-2900-2026Class II

GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011...

Name: Z-2900-2026 GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011...
Creator: Instrumentation Laboratory
Published: 2026-05-21
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2026-05-21 / Open, Classified / root cause: manufacturing process

FDA source

Instrumentation Laboratory began a recall of GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A on 2026-05-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2900-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-21
Posted: 2026-08-06
Recalling firm: Instrumentation Laboratory Co.
Product: GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 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.
Product codes and lots: Part No. 00055360010 UDI-DI 08426950807599 Lots 260505K, 260504AG, 260505F; Part No. 00055360011 UDI-DI 08426950807605 Lots 260505F and 260505J; Part No. 00055407504 UDI-DI 08426950807537 Lot 260505R; Part No. 00055415010 UDI-DI 08426950807698 Lots 260505H and 260505K; Part No. 00055430010 UDI-DI 08426950807759 Lots 260505H, 260505K and 260505F; Part No. 00055430011 UDI-DI 08426950807766 Lot 260505K; Product No. 00055445010 UDI-DI 08426950807810 Lots 260504AA and 260505K; Product No. 00055445011 UDI-DI 08426950807827 Lots 260505F and 260505J; Product No. 00055360010.A UDI-DI 08426950807599 Lot 260504AF;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2900-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2899-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-06
Z-2900-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-06

Product code CHL

K203790Class IIGEM Premier 5000Instrumentation Laboratory CO / cleared 2021-08-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)