Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0913-2018·Announced 2018-03-14

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.

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. 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
Category: Medical Device — In Vitro Diagnostic
Hazard: mis-labeling
inaccurate-results
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

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

See all →

High
Clinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
High
Laboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
High
VITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
High
FDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
High
Ortho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19

Same hazard · mis labeling