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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateSiemens Atellica CH Chemistry Calibrator Recalled for Calibration Errors
FDA (Devices) · 2020-07-01
- LowSiemens ADVIA Centaur Calibrator A Recalled for T4 Assay Inaccuracy
FDA (Devices) · 2013-08-21
- HighSiemens Vista Drug 4 Calibrator Recalled for Low Bias
FDA (Devices) · 2013-04-24
- LowSiemens Dimension IRON Calibrator Recalled for Calibration Slope Issues
FDA (Devices) · 2013-02-06
- HighSiemens Recalls ADVIA Chemistry A1c_3 Calibrators Due to Positive Bias
FDA (Devices) · 2013-09-11
- ModerateSiemens Recalls Insulin Calibrators Due to Measurement Deviation
FDA (Devices) · 2017-05-24