Recall Z-1470-2014 ยท KLT Enzyme Immunoassay, Carbamazepine
Ortho-Clinical Diagnostics
VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
| Date | Apr 17, 2014 (initiated Mar 5, 2014) |
| Status | Terminated |
| Reason | The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | The firm, Ortho Clinical Diagnostics, sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter (Ref. CL14-086; dated March 5, 2014) via FedEx Overnight Courier and/or US Postal Service Priority Mail (for PO Boxes only) to its US consignees (OCD Direct, Drop-Ship and US Federal Government). In addition, OCD proactively communicated with the 3 affected customers via phone to inform them of the potential issue and expedite product replacement. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue using and discard all remain |
| Quantity | 20 units |
| Distribution | US Distribution to states of: IN, MD, and TN. |
| 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 |