Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Immunoradiometric assay. Device is an immunoradiometric assay designed for the Recalled by Siemens Healthcare Diagnostics Due to The recall was initiated because Siemens Healthcare Diagnostics...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics directly.
Affected Products
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.
Quantity: Lot 742= 8 units all foreign consignees) Lot 743=7 units (all foreign consignees)
Why Was This Recalled?
The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H)
Where Was This Sold?
This product was distributed to 7 states: CA, GA, IL, IN, MI, MN, NY
About Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics has 27 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report