Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ort
FDA device recall Z-1016-05 · posted 2005-07-16 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Falsely elevated Carbamazepine results.
- Action taken
- Letters dated 5/26/05 with instructions to discontinue use and discard slides. Customers also instructed to review previous results with Laboratory Medical Director to determine need for further consultation with health care provider.
- Root cause
- Other
- Status
- Terminated
- Product code
- KLT
- Quantity affected
- 5,846 boxes
- Distribution
- 423 U.S. consignees nationwide, and 22 OCD/J&J foreign affiliates (Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Peru, Ecuador, India, Japan, Mexico, Panama, Singapore, Venezuela, Engl
- Date initiated
- 2005-05-26
- Date posted
- 2005-07-16
- Date terminated
- 2006-06-12
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS CHEMISTRY PRODUCTS CRBM SLIDES (K980283) | Johnson & Johnson Clinical Diagnostics, Inc. | 1998-02-25 |