Ortho-Clinical Recalls VITROS DAT Performance Verifier III Due to Labeling Error
Ortho-Clinical Diagnostics is recalling 180 units of VITROS DAT Performance Verifier III because incorrect storage labeling 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. The hazard involves a labeling error that affects test accuracy but does not involve a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 180 units of the VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic device. The recall is being conducted because the product is 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# 6802329 and Lot# K5618. The units were distributed worldwide, including in 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 stop using the affected product and contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- Product
- VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 180
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# 6802329 Lot# K5618
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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