Home / Recalls / Diagnostica Stago, Inc. / Z-1066-2018

Z-1066-2018 Class II Terminated

Recalled by Diagnostica Stago, Inc. — Parsippany, NJ

Recall Details

Product Type
Devices
Report Date
March 21, 2018
Initiation Date
October 25, 2017
Termination Date
May 12, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1636 Kits

Product Description

Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).

Reason for Recall

Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

Distribution Pattern

Nationally

Code Information

Lot 115080 (Exp: 01-2018) Lot 251241 (Exp: 01-2018)

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