Recall Z-0276-05 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
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 o
| Date | Dec 3, 2004 (initiated Oct 6, 2004) |
| Status | Terminated |
| Reason | 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 | 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 | 317,430 units total (5 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961965 | SURE CHECK PREGNANCY TEST Chembio Diagnostic Systems, Inc., Jun 24, 1996 |