Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0687-2019·Announced 2019-01-09

Ortho-Clinical Diagnostics Recalls VITROS Anti-HBe Reagent Packs

Ortho-Clinical Diagnostics is recalling VITROS Anti-HBe Reagent Packs because biased results may occur at lower biotin concentrations than indicated in the instructions.

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 the hazard involves potential test result bias rather than direct physical injury or reported illness, fitting the criteria for a moderate severity rating.

Plain-English summary

Ortho-Clinical Diagnostics is recalling VITROS Anti-HBe Reagent Packs, Catalog Number 6801816. This action extends a previous recall from July 2018 to include additional product codes. The recall covers 3,429 units, with each unit containing 100 tests.

The recall is being issued because biased results may occur for these additional products at biotin concentrations that are lower than indicated in the current Instructions for Use. The product is used for the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human serum.

The affected products were distributed worldwide, including nationwide in the United States and internationally to countries such as Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom. All expired, in-date, and future lots released are included in this recall. Users should stop using the affected reagent packs and contact the manufacturer for further instructions.

The recalled product

Product: VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who…
Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
Category: Medical Device — In Vitro Diagnostic
Hazard: test-accuracy

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 (3)

All expired
in-date
and future lots released.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · ORTHO-CLINICAL DIAGNOSTICS

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Same hazard · test accuracy