Siemens Recalls ADVIA Chemistry A1c_3 Calibrators Due to Positive Bias
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry A1c_3 Calibrators because they cause a positive bias of up to 12% in HbA1c test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a significant positive bias in diagnostic test results, which is a risk-of-harm product issue where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, due to a positive bias of up to 12% in HbA1c test results. The issue affects patient and CAP survey samples when using specific calibrator lots. The bias is caused by over-recovery, which exceeds the 7% acceptance criteria used for established ranges of CAP Survey Samples and IFCC sample recoveries.
The recall involves 1,546 units in the United States and 518 units distributed internationally. Affected lots include 1MD014 (expiration date 5/01/2013), 1BD063 (expiration date 5/01/2013), and 2GD014 (expiration date 10/01/2014). The products were distributed nationwide in the US, in Puerto Rico, and in numerous countries worldwide.
The issue may not have been detected depending on quality control limits. Siemens confirmed the bias during testing to confirm customer complaints. Users of these calibrators should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, N
- 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 (3)
- Lots 1MD014 (exp. date 5/01/2013)
- 1BD063 (exp. 5/01/2013)
- 2GD014 (exp. 10/01/2014)
Distribution
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