Siemens Chemistry Calibrator Recall for Direct Bilirubin Assay Shift
Siemens is recalling Chemistry Calibrators for the Direct Bilirubin Assay because reassigned System Specific Values may cause an average shift in results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential shift in diagnostic results, which fits the criteria for a moderate severity recall involving low-risk contamination or precautionary measures without reported harm.
Plain-English summary
Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator Lots 090445B and 090445C used with the ADVIA Chemistry Direct Bilirubin_2 Reagent. The affected calibrators are used with the ADVIA 1200, 1650, 1800, and 2400 Chemistry Systems. The recall involves 1,191 domestic units and 3,052 foreign units distributed worldwide.
The recall is due to reassigned System Specific Values (SSVs) for the Direct Bilirubin Assay (DBIL_2). Siemens determined that the SSVs currently assigned to these lots may cause an average shift in the quantitative determination of direct bilirubin in human serum and plasma. These measurements are used for screening liver function disorders or diagnosing jaundice.
The affected lots are 090445B (exp. 07/2014) and 090445C (exp. 10/2014). The product is identified by Siemens Material Number (SMN) 10312279, REF 09784096, and Part Number T03-1291-62. The source text does not specify specific consumer actions or report any illnesses or injuries.
The recalled product
- Product
- Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Product usage: Usage: DBIL_2: For in vitro diagnostic use in the quantitative determination of dir
- 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 090445B (exp. 07/2014) and 090445C (exp. 10/2014)
Distribution
Distributed nationwide across the United States.
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