VITROS Immunodiagnostic Products High Sample Diluent A recall
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Why was VITROS Immunodiagnostic Products High Sample Diluent A 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 2190; Product code(unique Device Identifier): 8430373 (10758750004898)
- Product
- VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 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.
- Recall date
- January 26, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)