Thyroglobulin assay reagent recalled after lot generated erroneously high patient results
Access Thyroglobulin assay reagent lot 439163 is recalled because it may generate erroneously high patient results, which could prompt unnecessary imaging or therapy changes. 453 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice states the reagent can produce erroneous patient results leading to unnecessary imaging or therapy changes.
Plain-English summary
The Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, catalog number 33860, UDI-DI 15099590227173, is being recalled for lot number 439163. The recall covers 453 units distributed in the United States and in Brazil, Canada, Georgia, Italy, Malaysia, Mexico, the Philippines and other countries.
The manufacturer determined that reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients being monitored for residual or recurrent thyroid cancer. The FDA classified the action as Class II.
Laboratories should check whether they hold lot 439163, stop using it, and follow the manufacturer's instructions on reviewing results already reported from that lot.
The recalled product
- Product
- Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 453
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 15099590227173
- Lot Number: 439163
Distribution
Distributed nationwide across the United States.
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