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.
This recall has been terminated (originally issued July 10, 2017).
- Company
- Ortho Clinical Diagnostics Inc
- Recall Initiated
- July 10, 2017
- Terminated
- August 6, 2020
- Recall Number
- Z-0807-2018
- Quantity
- 10,021 units
- Firm Location
- Raritan, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide
Lot / Code Info
Lot K4852, Expiration 22 Feb 2018
Root Cause
Unknown/Undetermined by firm
Action Taken
On July 10, 2017 the firm sent notification letters and an e-communications to their customers. Foreign customers were notified by email. Customers were instructed to complete a response form with the amount of product on hand and to discontinue use of the recalled product. For further questions, please call (585) 453-3452.
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