Beckman Coulter Recalls Access Free T3 Assay Kits Due to Result Shifts
Beckman Coulter is recalling Access Free T3 Assay kits because they may show an upward shift in patient results. The recall covers 205,744 kits distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves inaccurate diagnostic results (upward shift) which poses a risk of harm to patients through potential misdiagnosis, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Beckman Coulter Inc. is recalling the Access Free T3 Assay, Ref No. A13422. This product is a paramagnetic particle, chemiluminescent immunoassay used to measure free triiodothyronine levels in human serum and plasma. The recall involves 205,744 kits in total, with 13,358 kits distributed in the United States.
The recall was initiated because the assay kits have demonstrated an upward shift in patient results. This issue could affect the accuracy of laboratory testing for thyroid function. The affected lots are identified by specific code numbers listed in the official recall notice.
The product was distributed worldwide, including in the United States and numerous other countries. Healthcare facilities and laboratories that use the Access Immunoassay Systems should stop using the affected kits and contact Beckman Coulter for instructions on how to proceed.
The recalled product
- Product
- 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.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
Distribution
Distribution scope not specified by the agency.
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