VITROS Chemistry Products Performance Verifier is used recall
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…
Why was VITROS Chemistry Products Performance Verifier is used recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot K4852, Expiration 22 Feb 2018
- 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…
- Recalling firm
- Ortho Clinical Diagnostics Inc
- Quantity
- 10,021 units
- Distribution
- Worldwide
- Recall date
- March 7, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)