Recall Z-0503-2022 ยท PPM General Purpose Reagent
Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
| Date | Nov 22, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Ortho clinical Diagnostics issued an Important product correction notification on November 22, 2021. Actions to be taken by the Distributors: 1. Please provide the communication (Ref. CL2021-287) to customers who were shipped VITROS HSDA Lot 2190 from your facility. 2. Do not continue to distribute VITROS HSDA Lot 2190. 3. Complete the Confirmation of Receipt form no later than November 30, 2021. 4. Please forward this notification if the product was distributed outside of your facility. If you have questions, please contact our Ortho Care" Technical Solutions Center at 1-800-421-3311. Ac |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.