Ortho-Clinical Diagnostics: Medical Device Recall in 2014 - (Recall #: Z-1470-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 5, 2014

Date Posted: April 23, 2014

Recall Number: Z-1470-2014

Event ID: 67788

Reason for Recall:

The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403.

Status: Terminated

Product Quantity: 20 units

Code Information:

Lot 3920-0080-8403, expiry date 15-JUNE-2014

Distribution Pattern:

US Distribution to states of: IN, MD, and TN.

Voluntary or Mandated:

Voluntary: Firm initiated