VITROS Immunodiagnostic Products TT4 Reagent Pack, Product… recallZ-1834-2020 · Ortho Clinical Diagnostics · initiated Mar 10, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ortho Clinical Diagnostics or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
FDA root cause category: Under Investigation by firm
What the company is doing
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. All customers should return the completed form by March 25, 2020. " If you are satisfied with the product at this time but want Lot 2340 replaced in the future, you may resubmit the Confirmation of Receipt form at that time, indicating the quantity that requires replacement. " In the event of future occurrences, retain a copy of the Confirmation of Receipt form and re-submit if needed. " Please forward this notification if the product was distributed outside of your facility. Contact Information We apologize for the inconvenience this will cause your laboratory. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Recall details
- Recall number
- Z-1834-2020
- Status
- Terminated
- Initiated by the company
- Mar 10, 2020
- Recalling firm
- Ortho Clinical Diagnostics
- Quantity
- 3181
- Product code
- KLI
- FDA submissions
- K160495
- 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.
Product description
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Code information (models, lots, serial numbers)
UDI: 10758750005147; Lot Number: 2340
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 8744468Ortho Clinical Diagnostics · Enzyme immunoassay, non-radiolabeled, total thyroxine1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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