Z-1303-2024 Class II Ongoing
FDA device recall Z-1303-2024 was initiated by Beckman Coulter, Inc. on Feb 8, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 64,009 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 27, 2024
- Initiation Date
- Feb 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64,009 kits
Product Description
Reason for Recall
Distribution Pattern
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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1303-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026