STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 036074505901; Serial Numbers: CP86010393 DB68093186 CP87010814 CP86070669 CP86090743 CP86090744
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Diagnostica Stago, Inc.
- Reason for Recall:
- An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
Product Codes/Lot Numbers:
UDI-DI: 036074505901; Serial Numbers: CP86010393 DB68093186 CP87010814 CP86070669 CP86090743 CP86090744
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1575-2023
Related Recalls
Product: STA Liatest D-Di; REF: 00515;
Diagnostica Stago
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.