Stago recalls STA-Liquid Anti-Xa 4 kits (model 00311US) due to potential contamination with fibrinogen reagents in heparin tests. Affected users should contact Stago for details.
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Stago recalls its STA-Liquid Anti-Xa 4 kits (model 00311US) because they might mix with fibrinogen reagents used in heparin tests. This could lead to inaccurate test results if the kits are used with certain analyzers.
The kits could mix with fibrinogen reagents used in unfractionated heparin (UFH) and low molecular weight heparin (LMWH) tests. This contamination might cause inaccurate test results, but it does not cause direct harm to users.
Healthcare professionals using Stago's STA-Liquid Anti-Xa 4 kits for heparin level testing with specific analyzers are most at risk. Patients receiving these tests may be affected if the kits are used incorrectly.
Check for the model number 00311US on the kit packaging. The kits are intended for use with Stago STA-R, STA Compact, or STA Satellite analyzers for heparin level testing.
Reach out to Stago directly for specific instructions on how to handle the recalled kits.
The recall states there is a potential for contamination, but it does not indicate immediate harm. Users should contact Stago for guidance.
The recall does not specify a remedy, so contact Stago directly for instructions.
The kits are intended for use with Stago STA-R, STA Compact, and STA Satellite analyzers.
We’ve drafted a message you can send Stago to request your refund or repair — edit it as you like.
Subject: Recall Z-2474-2025 — Stago Stago Hello, I own a Stago that is covered by recall Z-2474-2025 from Stago. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
