Z-1819-2024Class II

VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the...

Name: Z-1819-2024 VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the...
Creator: Quidelortho
Published: 2024-04-09
License: https://open.fda.gov/license/

Quidelortho / initiated 2024-04-09 / Open, Classified / root cause: manufacturing process

FDA source

QUIDELORTHO began a recall of VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3)... on 2024-04-09. FDA classified it as Class II and gives the reason as "Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1819-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-09
Posted: 2024-05-14
Recalling firm: Quidelortho
Product: VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 111 2820
Product code: JIS Calibrator, Primary
Reason for recall: Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of other thyroid function tests.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: QuidelOrtho issued Important Product Correction Notification issued April 9, 2024. Letter states reason for recall, health risk and action to take: Discontinue using, render unusable, and discard affected lots of VITROS Free T3 Reagent Pack (and associated calibrators). " Complete the enclosed Confirmation of Receipt form no later than April 17, 2024. Upon receipt of your completed form, QuidelOrtho will provide credit for, or replacement of, discarded product. " Save this notification with your User Documentation or post this notification by each VITROS ECi/ECiQ/3600/5600/XT 7600 System until the issue has been resolved. " Please forward this notification if the affected product was distributed outside of your facility. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Global Services Organization. Resolution QuidelOrtho s investigation is on-going, and currently working to identify root cause. Contact Global Services Organization at 1-800-421-3311.
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore , Spain, Sweden, The Netherlands, United Kingdom.
Product codes and lots: UDI-DI: 10758750008438 Lot Numbers: 3042 Expiry: 09-Apr-2024; 3052 Expiry: 02-May-2024; 3061 Expiry: 06-Jun-2024; 3080 Expiry: 02-May-2024; 3090 Expiry: 14-Jun-2024; 3100 Expiry: 29-Jul-2024; 3110 Expiry: 13-Aug-2024; 3126 Expiry: 04-Sep-2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1819-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1818-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-14
Z-1819-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-14

Product code JIS

K994145Class IIVitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic Products Free T3 CalibratorsOrtho-Clinical Diagnostics, Inc. / cleared 1999-12-22

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)