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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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…
- 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.
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