Z-0470-06

Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of...

Name: Z-0470-06 Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of...
Creator: Chembio Diagnostic System Inc
Published: 2005-12-16
License: https://open.fda.gov/license/

Chembio Diagnostic Systems, Inc. / initiated 2005-12-16 / Terminated

FDA source

Chembio Diagnostic System Inc began a recall of 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... on 2005-12-16. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0470-06
Status: Terminated
Initiated: 2005-12-16
Posted: 2006-02-04
Terminated: 2006-06-30
Recalling firm: Chembio Diagnostic Systems, Inc.
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 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.
Product code: GHM Test, Sickle Cell
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.
FDA 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 in commerce: 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)
Product codes and lots: Lot SC050305, exp. 31OCT06; Lot SC062805, exp. 30NOV06

Product code GHM

K841272Class IISickle-Stat Hemoglobin S Screen KitClinical Technology Corp. / cleared 1984-04-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)