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Recall Observatory FDA recall evidence

Device product

VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0807-2018

July 10, 2017

Class III

Product summary

Firm
Ortho Clinical Diagnostics Inc
Event
Event 78724
Status
Terminated
Classification
Class III
Quantity
10,021 units
Official record key
device-enforcement:Z-0807-2018

Official wording

Reason: VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.

Code information: Lot K4852, Expiration 22 Feb 2018

Distribution pattern: Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.