VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20-
Summary
The FDA issued a Class II for VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITRO by Ortho-Clinical Diagnostics. Reason: Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. .
Details
Source
Device Recall
External ID
Z-2129-2023
Action Date
2023-07-19
Status
Ongoing
Category
device
Product Description
VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. Product Code: 6801704
Lot/Code Info: UDI-DI: 10758750006687 Lot Code: 2022 Exp. Date :06-Sept-2023
Quantity Affected: 2400 units
Reason for Recall
Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for IgG; +12.3% for IgA; -6.9% for C3; -6.6% for C4; and -17.8% for transferrin. Falsely elevated or reduced results could be reported depending on the analyte and/or sample concentration.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden , The Netherlands, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-08
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 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ortho-Clinical Diagnostics has 14 FDA actions in our database, including 5 recalls and 9 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) 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 have FDA actions?
Ortho-Clinical Diagnostics has 14 FDA actions in our database, including 5 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2129-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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