STA® - Néoplastine® CI Plus 10 00667Recalls & 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.

4 other recalls cover devices cleared under the same FDA submission (K922040); 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 24, 2018Class IITerminated

   QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)

   Z-2993-2018 · Root cause: Device Design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K922040. One submission often covers many models, so check the product and lot details in each record.

• Z-1066-2018 · Oct 25, 2017 · Terminated
  Neoplastine Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
• Z-1067-2018 · Oct 25, 2017 · Terminated
  Neoplastine Cl Plus (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).
• Z-1069-2018 · Oct 25, 2017 · Terminated
  STA - Neoplastine Cl Plus (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
• Z-0979-2007 · Mar 30, 2007 · Terminated
  STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT).