OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregnancy Test --- Description: the Sure Check hCG Midstream Pregnan
FDA device recall Z-0276-05 · posted 2004-12-03 · Terminated
Recall details
- Recalling firm
- Chembio Diagnostic System Inc
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LCX
- Quantity affected
- 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.
- Date initiated
- 2004-10-06
- Date posted
- 2004-12-03
- Date terminated
- 2005-03-24
- Location
- Medford, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURE CHECK PREGNANCY TEST (K961965) | Chembio Diagnostic Systems, Inc. | 1996-06-24 |