Reported Nov 11, 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. Intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest.
- 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
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Software Anomaly during ADD Installation on VITROS 5,1 FS Chemistry Systems using Software Versions 2.2.1 through 2.8. The user modified parameters would not be saved as expected, but remained changed to the default values obtained from the ADD disk.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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