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Diagnostica Stago, Inc. recalls Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
Recalled March 21, 2018 · FDA recall Z-1066-2018 · Diagnostica Stago
Hazard
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). · FDA Class II
Units
1636 Kits
Sold at
Nationally
Description
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Product
Neoplastine¿ Cl Plus @ (ref.00374) 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 →