Chembio Diagnostic System Inc OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregnancy Test --- Description: the Sure Check hCG Midstream Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic ''wand'' with an absorbent wick at one end. The device is packaged in a foil pouch with desiccant. Catalog numbers are solely used for ordering by the different distributors. This OTC product is shipped as either bulk packaged product o Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregnancy Test --- Description: the Sure Check hCG Midstream Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic ''wand'' with an absorbent wick at one end. The device is packaged in a foil pouch with desiccant. Catalog numbers are solely used for ordering by the different distributors. This OTC product is shipped as either bulk packaged product o
Brand
Chembio Diagnostic System Inc
Lot Codes / Batch Numbers
Lot U030504 (Exp. 30 AUG 06 - 49, 668 units distributed). ---Recall Expansion: lots U032904 (Exp. 31 AUG 06 - 47, 014 units distributed), U060804 (Exp. 30 NOV 06 - 62, 312 units distributed), U040104 (Exp. 30 SEP 06 - 83, 172 units distributed), U040904/1 (Exp. 30 SEP 06 - 75, 264 units distributed).
Products Sold
Lot U030504 (Exp. 30 AUG 06 - 49,668 units distributed). ---Recall Expansion: lots U032904 (Exp. 31 AUG 06 - 47,014 units distributed), U060804 (Exp. 30 NOV 06 - 62,312 units distributed), U040104 (Exp. 30 SEP 06 - 83,172 units distributed), U040904/1 (Exp. 30 SEP 06 - 75,264 units distributed).
Chembio Diagnostic System Inc is recalling OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregnancy Test --- Description: the Sure Check h due to Poor sealing of pouches and degradation of products. Firm received an e-mail from a distributor of an increase in complaints. In response to the compl. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Poor sealing of pouches and degradation of products. Firm received an e-mail from a distributor of an increase in complaints. In response to the complaints, the distributor conducted its own functional testing and noticed a degradation in performance of the two lots. Chembio's investigation revealed invalid results (no control lines) and some false negatives.
Recommended Action
Per FDA guidance
Recall letters on 10/6/04, followed by a second letter on/about 10/20/04. Recall letters mailed on 11/9/04 to cover recall expansion for 4 additional lots.
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 noticeDistribution
As reported by FDA
FL, IN, KS, KY, MA, NV, NY, NC, TN, WI, PR
Page updated: Jan 10, 2026