VITROS Chemistry CRP Slides Recalled for Incorrect Generation Labeling

Plain-English summary

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRP Slides due to labeling errors affecting product identification. The affected slides were incorrectly labeled with GEN 88 instead of the correct designation GEN 83 on the product carton, foil wrapper, and cartridge labels.

The incorrect generation designation could result in end-users selecting or installing the wrong generation of slides, potentially leading to improper device usage and diagnostic errors. No injuries or adverse events have been reported to date.

The recall affects 3,587 units distributed worldwide, including distribution in 29 US states (AR, AZ, CO, FL, GA, ID, IL, IN, KS, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WI, WV, WY) and in Canada, Chile, Colombia, France, India, Italy, Mexico, and Singapore. The affected lot numbers are: 3788-1291-0019, 3788-1291-0052, 3788-1291-0078, 3788-1291-0079, 3788-1291-0080, and 3788-1291-9975.

Customers who have received affected units should verify the generation designation on their cartridges against their instrument specifications and contact Ortho-Clinical Diagnostics if they believe they have received affected product.

The recalled product

Product

VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.

Manufacturer

Ortho-Clinical Diagnostics, Inc.

Category

Medical Device — Laboratory Diagnostic

Hazard

• mis-labeling
• device-misuse

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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