VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Summary
The FDA issued a Class II for VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 ( 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-1229-2024
Action Date
2024-03-13
Status
Ongoing
Category
device
Product Description
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Lot/Code Info: VITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750002979 Refurbished UD-DI 10758750007103 Serial Numbers: US: J36000109 J36000292 J36000489 J36000955 J36001167 J36001222 J36001283 J36001330 J36001348 OUS: J36000148 J36001000 J36001495 J36000340 J36001012 J36001513 J36000348 J36001024 J36001515 J36000406 J36001026 J36001519 J36000407 J36001027 J36001528 J36000427 J36001051 J36001530 J36000446 J36001088 J36001535 J36000511 J36001108 J36001558 J36000517 J36001111 J36001570 J36000580 J36001112 J36001573 J36000612 J36001117 J36001575 J36000626 J36001154 J36001579 J36000688 J36001229 J36001581 J36000753 J36001237 J36001582 J36000861 J36001245 J36001583 J36000877 J36001246 J36001595 J36000920 J36001401 J36001600 J36000923 J36001403 J36001602 J36000929 J36001427 J36001608 J36000933 J36001451 J36001618 J36000941 J36001488 J36001632 J36000942 J36001489 J36001640
Quantity Affected: 9 US; 66 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-1229-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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