FDA-Device2018-03-21Class II
Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
Diagnostica Stago, Inc.
Hazard
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Sold states
Nationally
Affected count
1636 Kits
Manufactured in
5 Century Dr, Parsippany, NJ, United States
Products
Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1066-2018Don't want to check this manually?
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