Diagnostica Stago, Inc.

7 FDA enforcement actions

7 Total Recalls

0 Class I

7 Class II

0 Class III

Firm Details

Product Types: device
States: NJ

All Recalls

Class II: Risk 12/15/2025 device

Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Class II: Risk 09/12/2025 device

A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Class II: Risk 07/21/2025 device

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Class II: Risk 07/21/2025 device

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Class II: Risk 07/21/2025 device

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Class II: Risk 07/21/2025 device

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Class II: Risk 05/21/2025 device

Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.