Recall Z-1336-04 ยท GHH Fibrin Split Products
Fisher Diagnostic, A Company of Fisher Scientific LLC
Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80 tests.
| Date | Aug 11, 2004 (initiated Jul 1, 2004) |
| Status | Terminated |
| Reason | Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples. |
| Root cause | Other |
| Action | The recalling firm notified consignees on 7/1/04 by letter flagged as a customer notification. The notice describes the potential for invalid control results using the speckled cards. The letter requests users to return the cards for replacement. Defective cards are described as isolated to those packaged in heat sealed cellophane type bags. The firm requests customers to return a response form with quantity needed for replacement. |
| Quantity | 5677 kits |
| Distribution | Product was sold primarily to clinical laboratories nationwide and to international distributors |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.