Ortho-Clinical Diagnostics: Medical Device Recall in 2014 - (Recall #: Z-0007-2015)

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 PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) 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: August 20, 2014

Date Posted: October 8, 2014

Recall Number: Z-0007-2015

Event ID: 69094

Reason for Recall:

Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased results were identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the same event, there is the potential for slides from this lot to also be affected.

Status: Terminated

Product Quantity: Domestic: 339 sales units; Foreign: 10 sales units

Code Information:

Lot Number 2613-0150-4913, exp. 15-Nov-2014

Distribution Pattern:

Distributed USA (nationwide) and in Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated