Siemens Healthcare Recalls TSH Calibrator Vials Due to Dose Recovery Issues
Siemens Healthcare Diagnostics is recalling specific lots of Coat-A-Consta IRMA TSH calibrators due to confirmed under-recovery of dose values.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Siemens Healthcare Diagnostics is recalling specific vials of Coat-A-Consta (CAC) IRMA TSH calibrators. The recall involves lots 969 and 970, which contain calibrators TSI4, TSI5, TSI6, TSI8, and TSI9. The affected vials can be identified by a darker yellow color than normal.
The recall was initiated because Siemens confirmed an under-recovery of dose values with these specific calibrator vials. The device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (TSH) in serum for in vitro diagnostic use.
The affected products 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. Users should identify affected vials by their darker yellow color and contact the manufacturer for 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
- Hazard
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 969 and 970
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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