Recall Z-1016-05 ยท KLT Enzyme Immunoassay, Carbamazepine
Ortho-Clinical Diagnostics
Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626.
| Date | Jul 16, 2005 (initiated May 26, 2005) |
| Status | Terminated |
| Reason | Falsely elevated Carbamazepine results. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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, England, France, Germany, Italy, Spain) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980283 | VITROS CHEMISTRY PRODUCTS CRBM SLIDES Johnson & Johnson Clinical Diagnostics, Inc., Feb 25, 1998 |