Z-0651-2019Class II

VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a...

Name: Z-0651-2019 VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a...
Creator: Ortho-Clinical Diagnostics
Published: 2018-10-19
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2018-10-19 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain... on 2018-10-19. FDA classified it as Class II and gives the reason as "Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent". 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-0651-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-19
Posted: 2018-12-20
Terminated: 2022-01-24
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: On October 19, 2018, Ortho Clinical Diagnostics issued "URGENT PRODUCT CORRECTION NOTIFICATION" notices via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers to inform them of the issue and actions to take to prevent occurrence of the anomaly. On November 19, 2018 Ortho Clinical Diagnostics re-issued correction notices to customers pertaining to the 5,1 FS system (CL2018-194_5,1FS). Customers may continue using their VITROS Systems and have been informed that the software issue will be mitigated with the next version of software. The expected dates of these software versions are included in the communication. Foreign affiliates were informed by email approximately on 21 October 2018 of the issue and instructed to notify their consignees of the issue and required actions to prevent the occurrence of the anomaly. Please refer to the Customer letter (Ref. CL2018-194_51FS, CL2018-194_3600, CL2018-194_4600, and CL2018-194_5600) for specific details on Required Actions by User. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 1105
Distribution: US Nationwide Distribution
Product codes and lots: Product code: 6801375 UDI: 10758750001132 Serial Numbers: J34000132- J34002322

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0651-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0650-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-20
Z-0651-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-20
Z-0652-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-20
Z-0653-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-20

Product code JJE

K063144Class IVitros 5,1 Fs Chemistry System with Engen Laboratory Automation SystemOrtho-Clinical Diagnostics, Inc. / cleared 2006-11-13

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)