Siemens Healthcare Recalls TSH Calibrator Vials Due to Dose Recovery Issues
Siemens Healthcare Diagnostics is recalling specific lots of TSH calibrator vials because they showed under-recovery of dose values.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics is recalling specific lots of Coat-A-Consta (CAC) IRMA TSH calibrator vials. The recall was initiated after the company confirmed an under-recovery of dose values in certain vials. The affected products include TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) from lot 035.
The affected calibrator vials can be identified by a darker yellow color than normal. The recall covers Lots 742 and 743, which were distributed worldwide, including in the United States (California, Georgia, Illinois, Indiana, Michigan, Minnesota, New York, and Puerto Rico) and internationally to Argentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, the Philippines, Paraguay, Taiwan, and Uruguay.
These devices are immunoradiometric assays designed for the quantitative measurement of thyroid stimulating hormone (TSH) in serum for in vitro diagnostic use. Users should stop using the affected vials and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.
- Manufacturer
- Siemens Healthcare Diagnostics
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 (1)
- Lots 742 and 743
Distribution
Part of a larger recall action
This product is one of 3 recalled by Siemens Healthcare Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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