Device product
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Z-0503-2022
Product summary
- 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
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.