Ortho-Clinical VITROS Performance Verifier IV Recall for Storage Labeling
Ortho-Clinical Diagnostics is recalling 196 units of VITROS Chemistry Products DAT Performance Verifier IV because storage labeling errors may cause lower than expected test results.
What this means for you
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 and involves a labeling error that affects test result accuracy without reports of direct physical injury or illness, fitting the criteria for moderate severity.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 196 units of the VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic. The recall is due to the product not meeting current storage labeling requirements for unopened units.
The labeling issue may cause customers to obtain lower than expected VITROS BENZ results when using this control material. The affected product is identified by Catalog# 6802330 and Lot# L5619.
The product was 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 contact Ortho-Clinical Diagnostics for further instructions regarding the recall.
The recalled product
- Product
- VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 196
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# 6802330 Lot# L5619
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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