VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics, Inc. has recalled VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190 due to the potential for lower than expected results when this diluent is used with VITROS Immunodiagnostic Products TSH Reagent Pack. The affected lot, identified by lot number 2190 and product code 8430373, consists of 1,416 units that were distributed worldwide, including to numerous U.S. states and countries such as Canada, Australia, the United Kingdom, Mexico, Japan, China, Brazil, and others.
The recall source does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: 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, Norwa Quantity: 1416 units Lot/code info: Lot # 2190; Product code(unique Device Identifier): 8430373 (10758750004898)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.