Laboratory diagnostic test may produce inaccurate results from reagent carryover
Siemens is recalling the Atellica CH Total Bilirubin diagnostic test because reagent carryover on the analyzer could produce falsely elevated results affecting multiple related lab tests.
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: This is an FDA Class II recall of a laboratory diagnostic device where reagent carryover could compromise test result accuracy. The hazard is theoretical with no illnesses or injuries reported, capping the severity at 3. However, inaccurate bilirubin measurements could significantly impact clinical decision-making, qualifying this as a risk-of-harm product without documented injury.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica CH Total Bilirubin_2, an in vitro diagnostic test used to measure bilirubin in blood samples. The product affects approximately 50,148 units distributed nationwide in the United States and internationally to Taiwan, Uruguay, and Vietnam. All lot numbers are included in this recall.
The recall addresses a potential for reagent carryover on the Atellica CH 930 analyzer that could cause falsely elevated (positively biased) test results. This issue could affect not only bilirubin measurements but also results from related tests performed on the same analyzer—LDL Cholesterol, Gamma-Glutamyl Transferase, and HDL Cholesterol tests. The carryover could impact quality control samples, patient diagnostic samples, and calibration materials.
Laboratories and healthcare facilities using this product should contact Siemens Healthcare Diagnostics and the FDA for guidance on this recall.
The recalled product
- Product
- Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 50,148
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)
- Unique Device Identification (UDI): 00630414595818 All Lot Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Siemens Healthcare Diagnostics, Inc. 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 4 products in this recall →Related recalls
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