Agency classClass IIOur severity:High FDA (Devices)·Z-3280-2018·Announced 2018-10-10

Ortho-Clinical VITROS Sodium Slides Recalled for Potential Positively Biased Results

Ortho-Clinical Diagnostics is recalling VITROS Sodium Slides due to a potential for positively biased results. The recall covers multiple generations and expiry dates distributed globally.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical diagnostic) where the hazard is potential bias in results, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Ortho-Clinical Diagnostics is recalling VITROS Sodium Slides, Catalog # 837 9034, due to a potential for positively biased results. The affected products include UDI 10758750004812 and Generations 8, 13, 14, 16, 17, and 18, with expiry dates ranging from November 1, 2018, to November 1, 2019.

The recall is classified as Class II by the U.S. Food and Drug Administration. The products were distributed in the United States and internationally, including Bermuda, Austria, Brazil, Canada, Colombia, China, India, Japan, Mexico, Singapore, the UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and the Netherlands.

Healthcare facilities and users of these diagnostic slides should stop using the affected products and contact Ortho-Clinical Diagnostics for further instructions on handling or returning the items.

The recalled product

Product: VITROS Sodium Slides, Catalog # 837 9034
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
diagnostic-error

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 (5)

UDI - 10758750004812 GENs- 8
13
14
16
17 & 18 Expiry Dates: 01-Nov-2018 through 01-Nov-2019

Distribution

Distributed nationwide across the United States.

Same manufacturer · Ortho-Clinical Diagnostics

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