Siemens Recalls Advia Chemistry Calibrator Due to Bilirubin Bias
Siemens is recalling Advia Chemistry Calibrators because incorrect values may cause a 41% positive bias in Direct Bilirubin patient 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 3/5 (High).
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 involves a medical device defect that results in significant diagnostic inaccuracy (41% bias), which poses a risk of harm through incorrect clinical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 10,614 units of Advia Chemistry Calibrators. The affected lots are 680726, 680726A, 680726B, 680726C, and 680726D. These devices are used for in vitro diagnostic calibration of ADVIA Chemistry systems.
The recall was initiated because the Assigned Calibrator Values (ACV) for the Direct Bilirubin (DBIL_2) method may cause a positive proportional bias of approximately 41% on patient samples compared to the reference method. This error could lead to inaccurate patient test results.
The affected products were distributed nationwide in the United States and internationally to numerous countries including Canada, Mexico, Australia, and various nations in Europe, Asia, and South America. Healthcare facilities and laboratories should stop using the affected calibrators and contact Siemens for instructions on replacement or return.
The recalled product
- Product
- Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 10,614
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 (5)
- Device Listing # D033650 Model# SMN# 10312279 Lot Numbers: 680726
- 680726A
- 680726B
- 680726C
- 680726D
Distribution
Distributed nationwide across the United States.
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