STA® - Staclot® Protein S 00746Recalls & reported problems
Diagnostica Stago · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
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.
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
- Jul 29, 2026Class IIOpen, Classified
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
Z-3047-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY devices
- STA® - Liatest® Free Protein S 6 00516Diagnostica Stago · TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY1 recall0 reports
- Factor VIII Chromogenic Assay 10445729Siemens Healthcare Diagnostics Products GmbH · TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY6 reports
- Protein C Reagent 10446185Siemens Healthcare Diagnostics Products GmbH · TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY2 reports
- Berichrom® Protein C 10446499Siemens Healthcare Diagnostics Products GmbH · TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY2 reports
- Factor VIII Antibody Screen F8SImmucor Gti Diagnostics, Inc. · Test, Qualitative And Quantitative Factor Deficiency1 report
- Protein S Ac 10445968Siemens Healthcare Diagnostics Products GmbH · TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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