Reported Mar 13, 2024 · Ongoing
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Ortho-Clinical Diagnostics, Inc.
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, Inc. · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
- Lot codes and dates
- VITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750012343 Refurbished
- UD-DI 10758750033201 Serial NumbersUS:
J46000208J46000209J46000240J46000497J46000864J46000865J46000898J46001030J46001064J46001125J46001132J46001293
- J46001462 J46001703 J46001704 OUS
J46000150J46000933J46000162J46001029J46000190J46001041J46000247J46001042J46000296J46001087J46000393J46001119J46000410J46001186J46000478J46001187J46000499J46001210J46000531J46001217J46000564J46001289J46000617J46001541J46000772J46001565J46000788J46001571J46000800J46001609J46000801J46001629J46000812J46001639J46000821J46001645J46000855J46001680J46000859J46000948J46000861J46000983J46000910
- Amount recalled
- 15 US; 43 OUS
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
Why it was recalled
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
This product could cause temporary or reversible health problems — stop using it.
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