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Recall Observatory FDA recall evidence

Device product

VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack

Z-0503-2022

November 22, 2021

Class II

Product summary

Firm
Ortho-Clinical Diagnostics, Inc.
Event
Event 89183
Status
Ongoing
Classification
Class II
Quantity
1416 units
Official record key
device-enforcement:Z-0503-2022

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.