The Recall Desk
HighFDA (Devices)·Z-2471-2023·Announced 2023-09-06

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.

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: 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.
Category
Medical Device — In Vitro Diagnostic Test
Hazard
  • reagent-carryover
  • test-result-bias

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.

Related recalls

Same category