Home / Recalls / Diagnostica Stago, Inc. / Z-1069-2018

Z-1069-2018 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

Product Description

STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) 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: 250041RX (Exp: 2018-02) Lot: 250077 (Exp: 2018-02) Lot: 250246RU (Exp: 2018-03) Lot: 251492 (Exp: 2018-09) Lot: 251308 (Exp: 2018-10) Lot: 251626 (Exp: 20 19-01) Lot: 251730 (Exp: 2019-02) Lot: 251772 (Exp: 2019-02)

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