Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in h
FDA device recall Z-0470-06 · posted 2006-02-04 · Terminated
Recall details
- Recalling firm
- Chembio Diagnostic System Inc
- 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.
- Action taken
- Chembio phoned the consignees and followed up by faxing the recall letters (dated 12/15/05) & response forms on 12/22/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- GHM
- Quantity affected
- 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)
- Date initiated
- 2005-12-16
- Date posted
- 2006-02-04
- Date terminated
- 2006-06-30
- 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 |
|---|---|---|
| SICKLE-STAT HEMOGLOBIN S SCREEN KIT (K841272) | Clinical Technology Corp. | 1984-04-13 |