Recall Z-1374-05 ยท GJT Plasma, Coagulation Factor Deficient
Dade Behring , Inc.
Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test
| Date | Aug 16, 2005 (initiated Jul 8, 2005) |
| Status | Terminated |
| Reason | sample may exhibit falsely high results |
| Root cause | Other |
| Action | On 7/13/05, the recalling firm issued letters to their customers informing them of the problem and the need to discontinue use and to discard any remaining product. |
| Quantity | 3255 packs |
| Distribution | The product was shipped to medical facilities and laboratories in AR, AZ, CA, FL, GA, ID, IL, IN, KS, KY, MA, MD, NC, ND, NV, NY, OH, OK, PA, TX, VA, WA, WI, and WV. The products were also shipped to Germany, Belgium, Switzerland, Sweden, Netherlands, Russia, Spain, France, Italy, Portugal, Australi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924396 | CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA Behring Diagnostics, Inc., May 21, 1993 |