Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
Reported: July 6, 2016 Initiated: June 8, 2016 #Z-2108-2016
Product Description
Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
Reason for Recall
Demonstrate an upward shift in patient results.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 205,744 kits total (13,358 kits in US)
- Distribution
- Worldwide Distribution - US Distribution and to the countries of : Algeria, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Ghana, Gibraltar, Greece, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, Zimbabwe
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.. Recalled by Beckman Coulter Inc.. Units affected: 205,744 kits total (13,358 kits in US).
Why was this product recalled? ▼
Demonstrate an upward shift in patient results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 6, 2016. Severity: Moderate. Recall number: Z-2108-2016.
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