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Diagnostica Stago, Inc. recalls STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
Recalled March 21, 2018 · FDA recall Z-1068-2018 · Diagnostica Stago
Hazard
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). · FDA Class II
Sold at
Nationally
Description
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Product
STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
Manufacturer(s)
Diagnostica Stago, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →