Z-1834-2020Class III

VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468

Name: Z-1834-2020 VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Creator: Ortho Clinical Diagnostics
Published: 2020-03-10
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2020-03-10 / Terminated / root cause: manufacturing process

FDA source

Ortho Clinical Diagnostics began a recall of VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468 on 2020-03-10. FDA classified it as Class III and gives the reason as "The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1834-2020
Classification: Class III
Status: Terminated
Initiated: 2020-03-10
Posted: 2020-04-30
Terminated: 2022-09-26
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Product code: KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Reason for recall: The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
Root cause tag: manufacturing process
FDA 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. 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.
Quantity in commerce: 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.
Product codes and lots: UDI: 10758750005147; Lot Number: 2340

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1834-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1834-2020	Class III	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-30

Product code KLI

K160495Class IIVITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc. / cleared 2016-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)