VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the
Summary
The FDA issued a Class III for VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagn by Ortho-Clinical Diagnostics, Inc.. Reason: May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU)..
Details
Source
Device Recall
External ID
Z-2225-2023
Action Date
2023-08-02
Status
Ongoing
Category
device
Product Description
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090
Lot/Code Info: UDI-DI: 10758750033324 Lot # 0090, Expiration Date: 19-Jun-2023
Quantity Affected: 2 units
Reason for Recall
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Distribution
US Nationwide distribution in the state of CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-18
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 191 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-2225-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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