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Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/E...

FDA Recall #Z-0844-2019 — Class II — November 29, 2018

Recall #Z-0844-2019 Date: November 29, 2018 Classification: Class II Status: Terminated

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

Reason for Recall

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

Recalling Firm

Ortho Clinical Diagnostics Inc — Raritan, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

4030

Distribution

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.

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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