Hybrid Capture II CT-ID Test, Catalog #5135-1050IVT, (labeled for export only).
FDA device recall Z-0657-03 · posted 2003-03-19 · Terminated
Recall details
- Recalling firm
- Digene Corp
- Reason for recall
- In Vitro diagnostic test kit may produce false positive patient results
- Action taken
- The firm notified consignees by phone and fax 2/7/03 and advised of potential for false positive patient results. Firms were instructed to destroy remaining inventory for replacement. Consignees were asked to return response form.
- Root cause
- Other
- Status
- Terminated
- Product code
- MAQ
- Quantity affected
- 272 kits/ 96 assays per kit
- Distribution
- Domestic product was sold to distributors and end users nationwide and to foreign consignees in Barbados and Spain. Product labeled for export only was distributed to Belgium, Brazil, France, Italy, P
- Date initiated
- 2003-02-07
- Date posted
- 2003-03-19
- Date terminated
- 2003-07-16
- Location
- Gaithersburg, MD
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYBRID CAPTURE II CT-ID TEST (K990023) | Digene Corp. | 1999-10-25 |