Access Thyroglobulin Calibrators Recalled for Inaccurate Test Results
Beckman Coulter recalls Access Thyroglobulin Calibrators that cause approximately 11% decrease in patient test results. The recall affects about 5,980 units distributed worldwide except the US, Canada, and China.
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: Score 3 per rubric: risk-of-harm product where injury has not yet been reported. The 11% measurement error in a thyroglobulin laboratory calibrator could impact clinical monitoring of cancer patients, though no illnesses have been reported.
Plain-English summary
Beckman Coulter, Inc. is recalling Access Thyroglobulin Calibrators that were distributed in April 2023 for use with Thyg reagent packs. An internal investigation determined that certain alternate thyroglobulin calibrator cards will cause a decrease of approximately 11% in patient test results.
The affected calibrators are identified by lot numbers 233806, 234171, 234355, 234443, 234444, 234617, and 337940, with UDI/DI 15099590227166. Approximately 5,980 units are affected.
The affected units were distributed worldwide, except in the United States, Canada, and China.
The recalled product
- Product
- Access Thyroglobulin Calibrators
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 5,980
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 (8)
- UDI/DI 15099590227166
- Serial/Lot Numbers: 233806
- 234171
- 234355
- 234443
- 234444
- 234617
- 337940
Distribution
Distribution scope not specified by the agency.
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