Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2122-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 10, 2025

Date Posted: July 23, 2025

Recall Number: Z-2122-2025

Event ID: 97047

Reason for Recall:

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).

Status: Ongoing

Product Quantity: 27, 330 US/ 19,679,730 OUS

Code Information:

Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides); UDI-DI: (1) 10758750000241, (2) 10758750004225; Lot Numbers: All lots within expiry.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated