STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT
FDA device recall Z-0979-2007 · posted 2007-07-03 · Terminated
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 170 units
- Distribution
- Nationwide.
- Date initiated
- 2007-03-30
- Date posted
- 2007-07-03
- Date terminated
- 2009-11-30
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEOPLASTINE CI PLUS (K922040) | American Bioproducts Co. | 1992-06-23 |