Z-1225-2024Class II

VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)

Name: Z-1225-2024 VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2024-01-26
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2024-01-26 / Open, Classified / root cause: software

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) on 2024-01-26. FDA classified it as Class II and gives the reason as "A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1225-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-26
Posted: 2024-03-01
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
Root cause tag: software
FDA root cause: Software Design Change
Action: On January 26, 2024, the firm sent a customer letter to all customers who have V3.8.1 installed on their VITROS Analyzer. Customers were informed of this issue and instructed to follow the instructions when using the VITROS System onboard QC package to update the QC baseline. The software will be updated to mitigate both issues within the VITROS Software QC feature. The estimated availability is 2Q2024. If you have further questions, please contact Global Services Organization at 1-800-421-3311.
Quantity in commerce: 4 US; 18 OUS
Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.
Product codes and lots: VITROS System Software Version 3.8.1 Regular UDI-DI 10758750012343 Refurbished UD-DI 10758750033201 Serial Numbers US: J46000240 J46000898 J46001030 J46001293 OUS: J46000150 J46001041 J46000190 J46001042 J46000499 J46001186 J46000564 J46001187 J46000801 J46001210 J46000821 J46001217 J46000910 J46001289 J46000933 J46001639 J46001029 J46001645

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1225-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1224-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1225-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1226-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1227-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1228-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01

Product code JJE

K031924Class IIVitros 5,1 Fs Chemistry System, Vitros Chemistry Products Dhdl Reagent Pack, Calibrator Kit 19, Fs Calibrator 1Ortho-Clinical Diagnostics / cleared 2003-08-07

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)