Recall Z-0807-2018— Ortho Clinical Diagnostics Inc
Class III · Terminated
Class III FDA medical device recall by Ortho Clinical Diagnostics Inc, initiated 2017-07-10, terminated 2020-08-06. It names one FDA 510(k) clearance: K042006. 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.. 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..
- Recalling firm
- Ortho Clinical Diagnostics Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2017-07-10
- Terminated
- 2020-08-06
- Firm location
- Raritan, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.