Ortho Clinical Diagnostics recalls VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740

Recall date: May 20, 2020
Source: U.S. Food & Drug Administration (FDA) — enforcement report
Recall number: Z-2482-2020
FDA classification: Class II
Brand / firm: Ortho Clinical Diagnostics
Sold / distributed: US Nationwide Distribution Foreign: Country AR AU BR CA CL CN CO DO FR ID IN JP KR MX MY NP PE PH SG TH TT VE VN

Why it was recalled

Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740

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