Ortho-Clinical VITROS DAT Performance Verifier V Recall for Storage Labeling Issues
Ortho-Clinical Diagnostics is recalling VITROS DAT Performance Verifier V units due to storage labeling errors that may cause lower than expected VITROS BENZ results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling error causing inaccurate results rather than a direct physical injury or high-risk pathogen, fitting the Moderate criteria for minor labeling errors.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 102 units of the VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic. The recall is due to the product not meeting current storage labeling requirements for unopened units. This labeling issue may cause customers to obtain lower than expected VITROS BENZ results when using the control.
The affected product is identified by Catalog# 6802331 and Lot# M5620. The units were distributed worldwide, including the United States (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.
Customers should check their inventory for the specific catalog and lot numbers listed above. If the product matches the recalled description, it should be removed from use to prevent inaccurate test results.
The recalled product
- Product
- VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 102
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 (1)
- Catalog# 6802331 Lot# M5620
Distribution
Part of a larger recall action
This product is one of 5 recalled by Ortho-Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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