Access TSH assay reagent packs may produce erroneously low results
Certain lots of Beckman Coulter Access TSH reagent packs may produce erroneously low thyroid-stimulating hormone results. Affected kits should be verified before clinical use.
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: This is a Class II recall for a diagnostic assay that may produce erroneous test results, which could lead to misdiagnosis or delayed diagnosis. No hospitalizations, injuries, or deaths have been reported, placing it within the High severity category for risk-of-harm products without reported injury.
Plain-English summary
Beckman Coulter, Inc. is recalling certain lots of Access TSH (3rd IS) reagent packs used with the Access Immunoassay Systems. The Access TSH assay is an in vitro diagnostic test that measures thyroid-stimulating hormone levels in blood samples. TSH measurements are used in the diagnosis of thyroid and pituitary disorders.
Certain lots of the Access TSH reagent packs may produce erroneously low TSH results. Erroneous results could lead to misdiagnosis or delayed diagnosis of thyroid or pituitary conditions.
Approximately 2,805 units have been distributed worldwide, including throughout the United States and in Austria, Belgium, Croatia, France, Germany, Ireland, Italy, Slovakia, Spain, Switzerland, and the United Kingdom. The affected lot numbers are 339117, 338724, 439341, 338367, 338057, and 234251.
Healthcare providers and laboratories using affected lot numbers should contact Beckman Coulter for guidance on replacement products or appropriate follow-up procedures. Patients who may have been tested using these reagent packs should consult their healthcare provider to discuss the potential impact on previous test results.
The recalled product
- Product
- The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid s
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- diagnostic-error
- inaccurate-measurement
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 (7)
- UDI/DI 15099590744373
- Lot Numbers: 339117
- 338724
- 439341
- 338367
- 338057
- 234251
Distribution
Distributed nationwide across the United States.
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