STA® - Liquid Anti-Xa 8 00322USRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K111822); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 21, 2025Class IIOpen, Classified

   Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

   Z-2475-2025 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111822. One submission often covers many models, so check the product and lot details in each record.

• Z-2474-2025 · Jul 21, 2025 · Open, Classified
  STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative d
• Z-2650-2014 · Jul 18, 2014 · Terminated
  Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determina