Summary
The FDA issued a Class II for Access Total T4, REF 33800, IVD, thyroxine reagent assay. by Beckman Coulter, Inc.. Reason: Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results..
Details
Source
Device Recall
External ID
Z-1303-2024
Action Date
2024-03-27
Status
Ongoing
Category
device
Product Description
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Lot/Code Info: Lot numbers: 338555, exp. 31 JUL 2024; 338556, exp. 31 AUG 2024; 338734, exp. 30 SEP 2024; and 338958, exp. 31 OCT 2024; UDI-DI 15099590225742.
Quantity Affected: 64,009 kits
Reason for Recall
Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.
Distribution
Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Bahrain, Bangladesh, Bolivia, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Egypt, El Salvador, Georgia, Greece, Hong Kong, India, Kazakhstan, Mexico, Namibia, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Taiwan, Thailand, Turkey, U.A.E, Vietnam, and Zimbabwe.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-08
Company
Chaska, MN
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 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter, Inc. has 158 FDA actions in our database, including 111 recalls and 47 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 (Beckman Coulter, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter, Inc. have FDA actions?
Beckman Coulter, Inc. has 158 FDA actions in our database, including 111 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1303-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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