Home / Recalls / Ortho-Clinical Diagnostics, Inc. / Z-2122-2025

Z-2122-2025 Class II Ongoing

Recalled by Ortho-Clinical Diagnostics, Inc. — Rochester, NY

FDA device recall Z-2122-2025 was initiated by Ortho-Clinical Diagnostics, Inc. on June 10, 2025 and is designated Class II. 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 rec… The recall status is ongoing. Affected quantity: 27, 330 US/ 19,679,730 OUS.

Recall Details

Product Type
Devices
Report Date
July 23, 2025
Initiation Date
June 10, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27, 330 US/ 19,679,730 OUS

Product Description

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

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).

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.

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.

Other recalls by Ortho-Clinical Diagnostics, Inc.

  • Z-2559-2025 Class II — Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains (July 29, 2025)
  • Z-2560-2025 Class II — VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = co (July 29, 2025)
  • Z-2335-2025 Class II — VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261; (July 9, 2025)
  • Z-2073-2025 Class II — VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS (June 12, 2025)
  • Z-2121-2025 Class II — Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products P (June 10, 2025)
  • Z-2123-2025 Class II — VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 (June 10, 2025)
  • Z-2120-2025 Class II — Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products P (June 10, 2025)
  • Z-2039-2025 Class II — Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Cata (May 9, 2025)
  • Z-2038-2025 Class II — Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog N (May 9, 2025)
  • Z-2040-2025 Class II — Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Nu (May 9, 2025)

FDA data resources