Recall Z-0042-05 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Dade Behring , Inc.
DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
| Date | Oct 23, 2004 (initiated Aug 27, 2004) |
| Status | Terminated |
| Reason | APTT determinations when using affected rotors may lead to incorrectly shortened times |
| Root cause | Other |
| Action | The recalling firm issued a recall letter dated 8/27/04 to their direct accounts informing them of the problem. The recalling firm also sent instructions for a work around until a solution can be established. |
| Quantity | 7140 units |
| Distribution | The product was shipped to medical facilities nationwide. The product was shipped to one government facility in TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011665 | BCT SYSTEM Dade Behring, Inc., Aug 9, 2001 |