VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Reported: January 26, 2022 Initiated: November 22, 2021 #Z-0503-2022
Product Description
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
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.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics, Inc.
- Units Affected
- 1416 units
- 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, Norway, Sweden, Belgium, The Netherlands.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack. Recalled by Ortho-Clinical Diagnostics, Inc.. Units affected: 1416 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 26, 2022. Severity: Moderate. Recall number: Z-0503-2022.
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