Z-2185-2019Class II

VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer

Name: Z-2185-2019 VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Creator: Ortho Clinical Diagnostics
Published: 2019-07-08
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2019-07-08 / Terminated / root cause: software

FDA source

Ortho Clinical Diagnostics began a recall of VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer on 2019-07-08. FDA classified it as Class II and gives the reason as "Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2185-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-08
Posted: 2019-08-06
Terminated: 2023-10-19
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Root cause tag: software
FDA root cause: Software design
Action: Customers were notified prior to July 10, 2019. For the VITROS 250, 250AT, and 350 chemistry system: Do not use VITROS Calibrator Kit 32 to calibrate assays until an Ortho trained service personnel reconfigures your system(s) with the correct parameters for VITROS Calibrator Kit 32. Complete the enclosed Confirmation of Receipt form no later than July 15, 2019. Post this notification by each system that may use VITROS Calibrator Kit 32 until your system is reconfigured by an Ortho trained representative. Please forward this notification if the product was distributed outside of your facility. For the VITROS 4600,5600 and 5,1 FS chemistry System: If your system is configured with User Modified parameters, choose an option provided in the Interim Resolutions section listed above. Install ADD DRV 6040 or above upon availability. Complete the enclosed Confirmation of Receipt form no later than July 15, 2019. Post this notification either by each system that processes VITROS Calibrator Kit 32 or with your user documentation until DRV 6040 or above is installed on your system(s). Please forward this notification if the product was distributed outside of your facility. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Distribution: Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
Product codes and lots: product code:6844508 UDI: 10758750032105 Affected Assay Data Disk (ADD) DRV No: DRV 6032 or above

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2185-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2174-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2175-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2176-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2177-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2178-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2179-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2180-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2181-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2182-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2183-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2184-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2185-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06

Product code JIX

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)