Z-2129-2023Class II

VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products...

Name: Z-2129-2023 VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products...
Creator: Ortho-Clinical Diagnostics
Published: 2023-05-08
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2023-05-08 / Open, Classified

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600... on 2023-05-08. FDA classified it as Class II and gives the reason as "Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2129-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-08
Posted: 2023-07-11
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. Product Code: 6801704
Product code: JIT Calibrator, Secondary
Reason for recall: Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for IgG; +12.3% for IgA; -6.9% for C3; -6.6% for C4; and -17.8% for transferrin. Falsely elevated or reduced results could be reported depending on the analyte and/or sample concentration.
FDA root cause: Under Investigation by firm
Action: QuidelOrtho (formerly Ortho Clinical Diagnostics) issued Urgent product correction Notification on 5/8/23. Letter states reason for recall, health risk and action to take: " Immediately discontinue using and discard your remaining inventory of VITROS Calibrator Kit 20, Lot 2022. QuidelOrtho will replace or credit your account. Indicate quantities to be replaced or credited on the attached Confirmation of Receipt form. " If you do not have an alternative lot of VITROS Calibrator Kit 20, you must discontinue reporting patient results using a Lot 2022 calibration. " Upon receipt of your replacement lot of VITROS Calibrator Kit 20, re-calibrate VITROS Transferrin, C3, C4, IgA, IgG and/or IgM assays on your VITROS System. " Complete the enclosed Confirmation of Receipt form . " Please forward this notification if the affected product was distributed outside of your facility. " Post this notification by your VITROS System(s) or with the user documentation until you receive your replacement order. Resolution Once we receive your completed Confirmation of Receipt form, QuidelOrtho will process your replacement order or credit your account. To provide replacement product for all customers, product allocation may be necessary. Contact Information . If you have further questions, please contact our Ortho Care Technical Solutions Center
Quantity in commerce: 2400 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden , The Netherlands, United Kingdom.
Product codes and lots: UDI-DI: 10758750006687 Lot Code: 2022 Exp. Date :06-Sept-2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2129-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2129-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-11

Product code JIT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)