Device product

STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).

Z-1069-2018

October 25, 2017

Class II

Product summary

Firm: Diagnostica Stago, Inc.
Event: Event 79292
Status: Terminated
Classification: Class II
Quantity: Unavailable
Official record key: device-enforcement:Z-1069-2018

Official wording

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

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)

Distribution pattern: Nationally

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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