RecallDepth

STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT).

Company
Diagnostica Stago, Inc.
Recall Initiated
March 30, 2007
Posted
July 3, 2007
Terminated
November 30, 2009
Recall Number
Z-0979-2007
Quantity
170 units
Firm Location
Parsippany, NJ

Reason for Recall

Based on the confirmed clotting times in the upper part of the assigned ranges of STA-Coag Control ABN control plasmas when used with STA-Neoplastine CI Plus, use of this lot may cause difficulty during the validation of the STA-Coag Control ABN.

Distribution

Nationwide.

Lot / Code Info

Lot 061781, June 2008

Root Cause

Other

Action Taken

Recall notification letters were sent on March 30, 2007 by first class mail. The letter advises customers that lot 061781 of STA-Neoplastine Cl Plus may cause difficulty during the vailidation process of STA-Coag Control ABN control plasmas, and asks that the lot number be discontinued.

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