VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Prod
Summary
The FDA issued a Class II for VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. by Ortho-Clinical Diagnostics, Inc.. Reason: Affected lots may experience increased calibration failures or an increase in falsely elevated results..
Details
Source
Device Recall
External ID
Z-0772-2024
Action Date
2024-01-31
Status
Ongoing
Category
device
Product Description
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Lot/Code Info: UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990
Quantity Affected: 6,920 US; 57 OUS
Reason for Recall
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
Distribution
Domestic distribution nationwide. OUS distribution to Bermuda, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, France, Belgium, and The Netherlands.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-27
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 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 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-0772-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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