Recall Z-1834-2020 · KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Ortho Clinical Diagnostics
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
| Date | Mar 10, 2020 |
| Status | Terminated |
| Reason | The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations. |
| Root cause | Under Investigation by firm |
| Action | IMPORTANT PRODUCT CORRECTION NOTIFICATION letters dated 3/10/20 were sent to customers. REQUIRED ACTIONS " If you have VITROS TT4 Reagent Packs Lot 2340 in your inventory, Ortho will replace or credit your account as indicated on your Confirmation of Receipt form. NOTE: As a reminder, if you have a successful calibration, and quality control results are acceptable, it is acceptable to continue using the affected lot. " Post this notification by each system that processes VITROS TT4 Reagent Packs, Lot 2340. " Complete the Confirmation of Receipt form now to register receipt of the notification |
| Quantity | 3181 |
| Distribution | US Nationwide. Australia, Bermuda, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160495 | VITROS® Automation Solutions Ortho-Clinical Diagnostics, Inc., Oct 18, 2016 |