Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0503-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack

Product Classification:

Class II

Date Initiated: November 22, 2021

Date Posted: January 26, 2022

Recall Number: Z-0503-2022

Event ID: 89183

Reason for Recall:

Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.

Status: Ongoing

Product Quantity: 1416 units

Code Information:

Lot # 2190; Product code(unique Device Identifier): 8430373 (10758750004898)

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KY, LA, MD, ME, MI, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, Belgium, The Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated