Z-2476-2025Class II

STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the...

Name: Z-2476-2025 STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the...
Creator: Diagnostica Stago, Inc.
Published: 2025-07-21
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2025-07-21 / Open, Classified

FDA source

Diagnostica Stago, Inc. began a recall of STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite... on 2025-07-21. FDA classified it as Class II and gives the reason as "Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2476-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-21
Posted: 2025-08-28
Recalling firm: Diagnostica Stago, Inc.
Product: STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of Clauss.
Product code: KQJ System, Fibrinogen Determination
Reason for recall: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
FDA root cause: Mixed-up of materials/components
Action: Diagnostica Stago notified consignees on about 07/21/2025 via emailed letter titled URGENT: MEDICAL DEVICE RECALL (CORRECTION). Consignees were instructed to temporarily systematically run a quality control just before a batch of UFH or LMWH, if you run STA-LIQUID ANTI-Xa in UFH and LMWH applications on your STA SATELLITE analyzer. This request is being asked while Stago works to develop a permanent solution for the analyzer. Consignees were also requested to complete and return the Acknowledgement Form and to notify customers if affected units were transferred or further distributed.
Quantity in commerce: 829,800 units (245,200 US)
Distribution: Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, France, French Polynesie, Guadeloupe, India, Iran, Israel, Jordan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Oman, Paraguay, Peru, Republique Tcheque, Romania, Saudi Arabia, Serbia, South Africa, Switzerland, Taiwan, Thailand, Tunisia, Turquie, United Arab Emirates, Uruguay, Vietnam.
Product codes and lots: Model/Catalog Number: 00674. UDI-DI: 13607450006749

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2476-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2473-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-29
Z-2474-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-29
Z-2475-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-29
Z-2476-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-29

Product code KQJ

K840211Class IIFibri-Prest Automate Ha34Wellcome Diagnostics / cleared 1984-03-02

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)