Z-1664-2023Class II

VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk...

Name: Z-1664-2023 VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk...
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2023-04-14
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2023-04-14 / Open, Classified / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through... on 2023-04-14. FDA classified it as Class II and gives the reason as "Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing". 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-1664-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-14
Posted: 2023-05-30
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of vancomycin (VANC). Product Code: 6801696
Product code: DLJ Calibrators, Drug Specific
Reason for recall: Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: QuidelOrtho (formerly Ortho Clinical Diagnostics) issued Urgent Product Correction Notification Letter on 4/14/23 to Distributors and End/Users. Letter states reason for recall, health risk and action to take: Prior to calibrating VITROS VANC Reagent GEN 50 using VITROS Calibrator Kit 11, Lot 1172, install ADD DRV 6224 or above on your VITROS System(s). " Complete the enclosed Confirmation of Receipt form no later than April 24, 2023. " Forward this notification if VITROS Calibrator Kit 11, Lot 1172 was distributed outside of your facility. " Save this notification with your user documentation or post this notification by each VITROS 5,1 FS/4600/5600/XT 7600 System until ADD DRV 6224 or above has installed. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Ortho Care" Technical Solutions Center. Contact Information If you have further questions, please contact the Ortho Care Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 132 units
Distribution: Nationwide Foreign: Brazil, Chile, Colombia
Product codes and lots: UDI-DI: 10758750006601 Lot Number: 1172 Exp. 20-OCT-2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1664-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1664-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-30

Product code DLJ

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)