Device product
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.
Z-1470-2014
Product summary
- Event
- Event 67788
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-1470-2014
Official wording
Reason: The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403.
Code information: Lot 3920-0080-8403, expiry date 15-JUNE-2014
Distribution pattern: US Distribution to states of: IN, MD, and TN.
Derived failure modes
-
Unknown
The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403.