STA® - Néoplastine® CI 10 00666Recalls & reported problems
Diagnostica Stago · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 other recall cover devices cleared under the same FDA submission (K922565); 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
- Jul 24, 2018Class IITerminated
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
Z-2994-2018 · Root cause: Device Design · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K922565. One submission often covers many models, so check the product and lot details in each record.
- Z-1068-2018 · Oct 25, 2017 · TerminatedSTA - Neoplastine Cl (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
Other TEST, TIME, PROTHROMBIN devices
- COAGUCHEK XS PT TEST 6 STRIP 4625374160Roche Diagnostics GmbH · TEST, TIME, PROTHROMBIN3 deaths1,681 reports
- CoaguChek XS PT strips 4625315160Roche Diagnostics GmbH · TEST, TIME, PROTHROMBIN604 reports
- CoaguChek XS Patient Self Testing Care Kit 03666794001Roche Diagnostics GmbH · Test, Time, Prothrombin212 reports
- CoaguChek XS Patient Self Testing Care Kit 4837738001Roche Diagnostics GmbH · TEST, TIME, PROTHROMBIN134 reports
- i-STAT 03P89-24Abbott Point Of Care Inc. · TEST, TIME, PROTHROMBIN127 reports
- HemosIL ReadiPlasTin (20 mL) 00020301400Instrumentation Laboratory Company · TEST, TIME, PROTHROMBIN2 recalls2 reports
- Coag-Sense Test Strip Kit, 50 ct. 100218Coagusense Inc. · Test, Time, Prothrombin1 recall0 reports
- Coag-sense 100218Coagusense Inc. · Test, Time, Prothrombin1 recall0 reports
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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