VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of t
Summary
The FDA issued a Class III for VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 Fo by Ortho-Clinical Diagnostics, Inc.. Reason: Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet con.
Details
Source
Device Recall
External ID
Z-0247-2022
Action Date
2021-11-24
Status
Terminated
Category
device
Product Description
VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
Lot/Code Info: Lot 1690 UDI 10758750001200
Quantity Affected: 191 units
Reason for Recall
Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results.
Distribution
US (Domestic) distribution to states of: AZ, CA, CO, CT, FL, GA, LA, MA, MO, NJ, NY, OK, SC, SD, TX, UT, WA, WI, and WV. OUS (Foreign) distribution to Colombia.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-15
Company
Rochester, NY
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 144 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 III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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-0247-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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