Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Reported: March 27, 2024 Initiated: February 8, 2024 #Z-1303-2024
Product Description
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
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.
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 64,009 kits
- 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.
- Location
- Chaska, MN
Frequently Asked Questions
What product was recalled? ▼
Access Total T4, REF 33800, IVD, thyroxine reagent assay.. Recalled by Beckman Coulter, Inc.. Units affected: 64,009 kits.
Why was this product recalled? ▼
Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 27, 2024. Severity: Moderate. Recall number: Z-1303-2024.
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