Diagnostica Stago, Inc. recalls STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
- Recall date
- October 25, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1069-2018
- FDA classification
- Class II
- Brand / firm
- Diagnostica Stago, Inc.
- Sold / distributed
- Nationally
Why it was recalled
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
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