FDA-Device2025-07-23Class II

VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);

Ortho-Clinical Diagnostics, Inc.

Hazard

Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).

Sold states

Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, GA, IL, MD, MI, MO, MS, NY, TN, TX, VA; and OUS (International) to countries of: Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.

Affected count

27, 330 US/ 19,679,730 OUS

Manufactured in

100 Indigo Creek Dr, N/A, Rochester, NY, United States

Products

VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2122-2025

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