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Ortho Clinical Diagnostics recalls VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758
Recalled July 8, 2020 · FDA recall Z-2484-2020 · Ortho Clinical Diagnostics
Hazard
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances · FDA Class II
Units
Total= 353 ( U.S.= 167; OUS 186)
Sold at
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
Description
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Product
VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
Manufacturer(s)
Ortho Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →