Reported Sep 9, 2015 · Terminated
VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and…
Ortho-Clinical Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644, IVD --- Ortho Clinical Diagnostics Inc. The VITROS 5,1 FS Chemistry System with enGEN Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
- Lot codes and dates
Software Versions 2.2.1 through 2.8Catalog # 6801375
- Serial Numbers
34000119 through 34002323Catalog # 6801890
- Serial Numbers
63 of 63 codes
J34000133J34000193J34000197J34000212J34000285J34000316J34000318J34000337J34000360J34000420J34000451J34000478J34000495J34000497J34000529J34000538J34000552J34000557J34000590J34000596J34000601J34000631J34000642J34000761J34000799J34000805J34000833J34000851J34000893J34000946J34000947J34001006J34001172J34001218J34001240J34001243J34001248J34001251J34001274J34001297J34001311J34001317J34001345J34001378J34001379J34001389J34001390J34001396J34001422J34001472J34001504J34001569J34001572J34001612J34001626J34001633J34001668J34001755J34001809J34001840
- Amount recalled
- Catalog 6801375: Domestic 919; Foreign 1251; Catalog 6801890: Domestic 63, Foreign 147
Where it was sold
- Nationwide
- PR
Why it was recalled
Software anomaly may occur during the installation of an Assay Data Diskette (ADD) using Software Versions 2.2.1 through 2.8. If the user is utilizing User- Configured (Modified) parameters, ALL default settings are restored in the VITROS 5,1 FS Chemistry System from the ADD instead of retaining the user modified parameters.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Ortho-Clinical Diagnostics recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.