The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0914-2018·Announced 2018-03-14

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.

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 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
Category
Medical Device — In Vitro Diagnostic
Hazard
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

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 →

Related recalls

Same manufacturer · Ortho-Clinical Diagnostics

See all →

Same hazard · mis labeling

See all →

Similar recalls