Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);

Recalled July 23, 2025 · FDA recall Z-2123-2025 · Ortho-Clinical Diagnostics

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). · FDA Class II

Units

414,000 (OUS)

Sold at

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.

Description

Product

VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);

Manufacturer(s)

Ortho-Clinical Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →