Recall Z-0773-04 ยท GFO Activated Partial Thromboplastin
Dade Behring , Inc.
Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials
| Date | Jul 20, 2004 (initiated Mar 1, 2004) |
| Status | Terminated |
| Reason | cloudy appearance or precipitate |
| Root cause | Other |
| Action | The recalling firm issued recall letters dated 3/4/04 to their direct accounts informing them of the problem and what to do if a vial is found to be cloudy. |
| Quantity | 77886 vials |
| Distribution | The products were shipped to one diagnostic facility in PA. The products were also shipped to Germany, Poland, Spain, France, Italy, Portugal, Mexico, Thailand, and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955450 | PATHROMTIN SL Behring Diagnostics, Inc., Apr 19, 1996 |