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 DIAGNOSTIC SYSTEMS, INC., MEDFORD, NY 11763 --- Accessories available: SC902: Sickle-STAT 5-place Ob Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 Ob
Brand
Chembio Diagnostic System Inc
Lot Codes / Batch Numbers
Lot SC050305, exp. 31OCT06, Lot SC062805, exp. 30NOV06
Products Sold
Lot SC050305, exp. 31OCT06; Lot SC062805, exp. 30NOV06
Chembio Diagnostic System Inc is recalling Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Chembio phoned the consignees and followed up by faxing the recall letters (dated 12/15/05) & response forms on 12/22/05.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026