Ortho Recalls VITROS Performance Verifier II Due to Stability Issues
Ortho Clinical Diagnostics is recalling VITROS Performance Verifier II Lot K4852 because it fails long-term stability requirements for the AST analyte when refrigerated.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Ortho Clinical Diagnostics Inc is recalling 10,021 units of VITROS Performance Verifier II, Lot K4852, which has an expiration date of February 22, 2018. The product was distributed worldwide.
The recall was initiated because the specific lot does not meet long-term stability requirements for the AST analyte when the product is stored refrigerated for up to six months. The VITROS Performance Verifier II is used as an assayed control to monitor the performance of VITROS 250/350/5, 1 FS, and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Users of this product should stop using the affected lot and contact Ortho Clinical Diagnostics for further instructions. This recall is classified as Class III by the FDA, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- 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…
- Manufacturer
- Ortho Clinical Diagnostics Inc
- Hazard
- Affected units
- 10,021
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot K4852
- Expiration 22 Feb 2018
Distribution
Distribution scope not specified by the agency.
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