Ortho VITROS Chemistry Performance Verifier II Recalled for Product Instability
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Performance Verifier II due to product instability that causes biased ALKP values.
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 by definition is unlikely to cause adverse health consequences, fitting the Low severity criteria for documentation or minor issues.
Plain-English summary
Ortho Clinical Diagnostics Inc is recalling VITROS Chemistry Products Performance Verifier II, an assayed control used to monitor performance on various VITROS Chemistry Systems. The recall is due to product instability that results in biased alkaline phosphatase (ALKP) values when the product is stored unopened at refrigerated temperatures.
The affected product is Lot Q7692, with an expiration date of 01-NOV-2021. The recall involves 10,788 total units, distributed worldwide including the United States, Australia, Canada, and several European and Asian countries. This is a Class III recall, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Healthcare facilities and laboratories should stop using the affected lot and contact Ortho Clinical Diagnostics for instructions on return or disposal. Consumers are not directly affected as this is an in vitro diagnostic product used in professional settings.
The recalled product
- Product
- VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated…
- Manufacturer
- Ortho Clinical Diagnostics Inc
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 Q7692
- EXP: 01-NOV-2021 UDI: 10758750004577
Distribution
Distributed nationwide across the United States.
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