Agency classClass IIOur severity:High FDA (Devices)·Z-2066-2012·Announced 2012-08-01

Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS System Software

Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS System Software versions 2.6.1 and below because the software may fail to verify quality assessments when reagent lots are switched.

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. The hazard involves a lack of verification of quality assessment for clinical analytes, which poses a risk of harm through inaccurate results, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Ortho-Clinical Diagnostics is recalling 2,044 units of VITROS 5,1 FS System Software, versions 2.6.1 and below. The software is used for the in-vitro quantitative, semi-quantitative, and qualitative measurement of various analytes of clinical interest.

The recall is due to a defect where the software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted, or when an operator manually changes the lot in use. This behavior causes a lack of verification of proper quality assessment.

The affected software was distributed worldwide, including in the United States, Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraguay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, the UK, Northern Europe, France, Germany, Italy, Spain, and Portugal. Users should contact Ortho-Clinical Diagnostics for further instructions.

The recalled product

Product: VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — Laboratory Software
Hazard: quality-assessment-failure
inaccurate-results
Affected units: 2,044

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)

Version 2.6.1 & Below

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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