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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 22 Results
510(K) Number: K063144
 
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Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-a... 2 06/08/2015 FEI # 1000136573
Ortho-Clinical Diagnostics
Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trad... 2 04/25/2015 FEI # 1000136573
Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. T... 2 10/16/2014 FEI # 1000136573
Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measure... 2 12/20/2018 FEI # 1000136573
Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System, clinical chemistry analyzer 2 08/06/2019 FEI # 1000136573
Ortho Clinical Diagnostics
VITROS 4600 Chemistry System, clinical chemistry analyzer 2 08/06/2019 FEI # 1000136573
Ortho Clinical Diagnostics
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 107587500011... 2 03/08/2016 FEI # 1000136573
Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measure... 2 12/20/2018 FEI # 1000136573
Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer 2 08/06/2019 FEI # 1000136573
Ortho Clinical Diagnostics
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer 2 08/06/2019 FEI # 1000136573
Ortho Clinical Diagnostics
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