Ortho-Clinical Diagnostics: Medical Device Recall in 2018 - (Recall #: Z-0913-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic

Product Classification:

Class II

Date Initiated: September 22, 2017

Date Posted: March 14, 2018

Recall Number: Z-0913-2018

Event ID: 79155

Reason for Recall:

This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.

Status: Terminated

Product Quantity: 180

Code Information:

Catalog# 6802329 Lot# K5618

Distribution Pattern:

Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.

Voluntary or Mandated:

Voluntary: Firm initiated