Recall Z-0979-2007 ยท GJS Test, Time, Prothrombin
Diagnostica Stago, Inc.
STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT).
| Date | Jul 3, 2007 (initiated Mar 30, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 170 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922040 | NEOPLASTINE CI PLUS American Bioproducts Co., Jun 23, 1992 |