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 and a darker yellow color.
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 recall is classified as FDA 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 lots of Coat-A-Consta (CAC) IRMA TSH calibrators. The affected products include TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) from lot 035. The recall was initiated after the manufacturer confirmed an under-recovery of dose values in some of these vials.
The affected calibrator vials can be identified by a darker yellow color than normal. The source text notes that TSI3 (level A), TSI7 (level E), and TSIX (level H) are not part of this specific description of affected vials. The recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recall covers worldwide distribution, including the United States (specifically CA, GA, IL, IN, MI, MN, NY, and Puerto Rico) and international locations such as Argentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, the Philippines, Paraguay, Taiwan, and Uruguay. Users should stop using the affected vials and contact the manufacturer for instructions.
The recalled product
- Product
- Immunoradiometric assay.
- 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 831 and 832
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.
See all 3 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics
See all →- ModerateSiemens BC Thrombin Reagent Kit Recall for Unexpected Prolonged Results
FDA (Devices) · 2018-03-07
- ModerateSiemens IMMULITE 1000 Cortisol Assay Recalled for Positive Bias
FDA (Devices) · 2014-10-29
- ModerateSiemens Recalls ADVIA Centaur XP Immunoassay Systems Due to Data Error
FDA (Devices) · 2014-10-08
- ModerateSiemens Recalls ADVIA Centaur Immunoassay Systems Due to Data Error
FDA (Devices) · 2014-10-08
- ModerateSiemens ADVIA Centaur Immunoassay System Field Correction for Sample Rack Loading
FDA (Devices) · 2014-09-24
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02