Summary
The FDA issued a Class II for VITROS XT 3400 Chemistry System, Catalog No. 6844458 by Ortho-Clinical Diagnostics, Inc.. Reason: 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 ex.
Details
Source
Device Recall
External ID
Z-1232-2024
Action Date
2024-03-13
Status
Ongoing
Category
device
Product Description
VITROS XT 3400 Chemistry System, Catalog No. 6844458
Lot/Code Info: VITROS System Software Versions 3.8.0 or 3.8.1 UDI-DI 10758750031986 Serial Numbers: US: J34500140 J34500180 J34500257 J34500289 J34500319 J34500386 J34500422 J34500447 J34500473 J34500474 J34500510 J34500539 J34500547 J34500579 J34500588 J34500622 J34500656 J34500777 J34500818 J34500861 J34500887 J34500893 J34500896 J34500911 J34500931 OUS: J34500123 J34500128 J34500129 J34500130 J34500190 J34500261 J34500269 J34500271 J34500292 J34500301 J34500337 J34500356 J34500363 J34500515 J34500520 J34500536 J34500582 J34500609 J34500628 J34500658 J34500711 J34500793 J34500802 J34500940 J34500960 J34500962
Quantity Affected: 25 US; 26 OUS
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-26
Company
Rochester, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ortho-Clinical Diagnostics, Inc. has 71 FDA actions in our database, including 67 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ortho-Clinical Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ortho-Clinical Diagnostics, Inc. have FDA actions?
Ortho-Clinical Diagnostics, Inc. has 71 FDA actions in our database, including 67 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1232-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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