Recall Z-0470-06 ยท GHM Test, Sickle Cell
Chembio Diagnostic System Inc
Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in human blood --- FOR IN VITRO DIAGNOSTIC USE --- FOR PROFESSIONAL USE ONLY --- Contents: 48 pre-filled Sickle-STAT reaction tubes containing sodium hydrosulfite. 1 bottle phosphate buffer containing surfactant and stabilizer, and 1 Instruction leaflet. --- manufactured by: CHEMBIO
| Date | Feb 4, 2006 (initiated Dec 16, 2005) |
| Status | Terminated |
| Reason | Firm received one report of a false negative with the positive control. Internal testing by the firm has shown that the kit lot may result in invalid or false negative interpretations. |
| Root cause | Other |
| Action | Chembio phoned the consignees and followed up by faxing the recall letters (dated 12/15/05) & response forms on 12/22/05. |
| Quantity | Lot SC050305: 347 test kits, Lot SC062805: 410 test kits |
| Distribution | Medical facilities and a few distributors located nationwide, the Dominican Republic, and West Indies (St. Vincent & Grenadine) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K841272 | SICKLE-STAT HEMOGLOBIN S SCREEN KIT Clinical Technology Corp., Apr 13, 1984 |