Ortho Clinical Diagnostics Inc: Medical Device Recall in 2019 - (Recall #: Z-0844-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma

Product Classification:

Class II

Date Initiated: November 29, 2018

Date Posted: February 27, 2019

Recall Number: Z-0844-2019

Event ID: 81767

Reason for Recall:

A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.

Status: Terminated

Product Quantity: 4030

Code Information:

Lots 1271 through 1310 (expired) Lots 1315 & Above (in-date)

Distribution Pattern:

Distributed nationwide domestically. Foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and the Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated