Recalls / —

—#180459

Product

VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468

FDA product code

KLI — Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K160495

Affected lot / code info

UDI: 10758750005147; Lot Number: 2340

Why it was recalled

The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Ortho Clinical Diagnostics

Address

100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2020-03-10

Terminated

2022-09-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #180459. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.