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 DIAGNOSTIC SYSTEMS, INC., MEDFORD, NY 11763 --- Accessories available: SC902: Sickle-STAT 5-place Observation rack, SC903: Sickle-STAT Hemoglobin S Control Set; 4 x 1 vials: 2 A/A negative and 2 A/S positive, SC904: Sickle-STAT Phosphate Buffer, 200 ml.
This recall has been terminated (originally issued February 4, 2006).
- Company
- Chembio Diagnostic System Inc
- Recall Initiated
- December 16, 2005
- Posted
- February 4, 2006
- Terminated
- June 30, 2006
- Recall Number
- Z-0470-06
- Quantity
- Lot SC050305: 347 test kits, Lot SC062805: 410 test kits
- Firm Location
- Medford, NY
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Medical facilities and a few distributors located nationwide, the Dominican Republic, and West Indies (St. Vincent & Grenadine)
Lot / Code Info
Lot SC050305, exp. 31OCT06; Lot SC062805, exp. 30NOV06
Root Cause
Other
Action Taken
Chembio phoned the consignees and followed up by faxing the recall letters (dated 12/15/05) & response forms on 12/22/05.