FDA Device

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

Hazard

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.

What You Should Do

Remedy

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.

Products

STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT).
Brand
Diagnostica Stago, Inc.
UPC
Lot 061781, June 2008

Units Affected

170 units