VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Summary
The FDA issued a Class II for VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 684 by Ortho-Clinical Diagnostics, Inc.. Reason: Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to.
Details
Source
Device Recall
External ID
Z-1676-2022
Action Date
2022-09-14
Status
Ongoing
Category
device
Product Description
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Lot/Code Info: UDI-DI: 10758750031610 Systems start with 7600XXXX where XXXX is unique for each analyzer
Quantity Affected: 1148 units
Reason for Recall
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-19
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 134 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-1676-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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