FDA Enforcement
Class II
Terminated
Access Free T3 Reagent Kit, P/N 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.
Recall: Z-0110-2016
·
Reported October 14, 2015
Enforcement
- Recall Number
- Z-0110-2016
- Event ID
- 72090
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Beckman Coulter Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 14, 2015
- Initiation Date
- August 31, 2015
- Classification Date
- October 7, 2015
- Termination Date
- May 16, 2016
- Address
- 250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States
Description
Access Free T3 Reagent Kit, P/N 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
Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells.
Code Info
Lot: 431433
Distribution
Worldwide Distribution - US (nationwide) and to the countries of : Australia, Brazil, Canada, China, Colombia, Costa Rica, Hong Kong, Israel, Japan, Kuwait, Macao, Malaysia, Mexico, New Zealand, Saudi Arabia, Singapore, Taiwan, Thailand and Viet Nam.
Quantity
16,648 units total (1874 units in US)