Z-0277-05

OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG...

Name: Z-0277-05 OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG...
Creator: Chembio Diagnostic System Inc
Published: 2004-10-06
License: https://open.fda.gov/license/

Chembio Diagnostic Systems, Inc. / initiated 2004-10-06 / Terminated / root cause: packaging

FDA source

Chembio Diagnostic System Inc began a recall of OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow... on 2004-10-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0277-05
Status: Terminated
Initiated: 2004-10-06
Posted: 2004-12-03
Terminated: 2005-03-24
Recalling firm: Chembio Diagnostic Systems, Inc.
Product: OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic cassette. It differs from the Sure Check Midstream product in that the lateral flow membrane pad is placed in a cassette and the urine sample is added by pipette rather than by urinating on the absorbent wick. The device is packaged in a foil pouch with desiccant. This product is shipped as bulk packaged product of varying quantities (Catalog # PT127-OTC ordered by Innovative Chemical Co., and Pruebas Moderna Del Istmo; Catalog # PT210 ordered by LABSCO). --- 510(k) K933529/A.
Product code: LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Other
Action: 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.
Quantity in commerce: 42,005 (total of 2 lots)
Distribution: Distributors in KS, TN, NC, MA, NY, KY, FL, NV, and Puerto Rico for further distribution to their retail customers. Products also distributed to accounts in Barbados WI, Israel, Costa Rica and Canada.
Product codes and lots: Lot U040904 (Exp. 30 SEP 06) ; Recall Expansion: lot U032904/1 (Exp. 30 AUG 06 - 14,364 units distributed)

Product code LCX

K933529Class IEyeglasses FramesVistula Assistance & Consulting Bureau / cleared 1993-10-20

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)