Recall Z-1496-04 ยท GHM Test, Sickle Cell
Fisher Diagnostic, A Company of Fisher Scientific LLC
Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations.
| Date | Sep 30, 2004 (initiated Sep 3, 2004) |
| Status | Terminated |
| Reason | Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives. |
| Root cause | Other |
| Action | The firm ceased distribution on 8/24/04 and initiated recall by certified letter dated 9/3/04, which was flagged as 'customer recall notification'. The notice advised of the defective vials and requested users to return response form with the numbers of kits to be returned for replacement. |
| Quantity | 604 kits |
| Distribution | Product was distributed through the manufacturer''s affiliate distribution company to 228 end users nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K854079 | THROMBO SCREEN SICKLE CELL ASSAY SET Pacific Hemostasis, Oct 31, 1985 |