Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0912-2018·Announced 2018-03-14

Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products DAT Performance Verifier II

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products DAT Performance Verifier II because storage labeling errors 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 and involves a labeling error that affects test accuracy without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Ortho-Clinical Diagnostics is recalling 323 units of VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic products. 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. The affected product is identified by Catalog# 6802328 and Lot# J5617.

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 stop using the affected product and contact Ortho-Clinical Diagnostics for further instructions.

The recalled product

Product: VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
inaccurate-results
Affected units: 323

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# 6802328 Lot# J5617

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 5 products in this recall →

Same manufacturer · Ortho-Clinical Diagnostics

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Same hazard · mis labeling