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Ortho-Clinical Diagnostics, Inc. Recall 89183

Description: VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack

Ortho-Clinical Diagnostics, Inc. Recall 89183 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0503-2022
Event ID89183
Event DescriptionVITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Product TypeDevices
DistributionWorldwide 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.
Quantity1416 units
Recall ReasonLower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.
Device Classification20220126
Device Code InfoLot # 2190; Product code(unique Device Identifier): 8430373 (10758750004898)
Center Classification Date20220118
Recall Initiation Date20211122
Recalling FirmOrtho-Clinical Diagnostics, Inc.
Initial Notification Letter
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