The Recall Desk
HighFDA (Devices)·Z-2472-2023·Announced 2023-09-06

Siemens Atellica CH LDL Cholesterol analyzer reagent carryover issue

Siemens is recalling Atellica CH analyzers due to potential reagent carryover that can cause falsely elevated results in cholesterol, bilirubin, and liver enzyme tests. This could affect the accuracy of patient laboratory results.

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 diagnostic device recall involving potential analytical errors in critical laboratory tests. Although no illnesses or injuries have been reported, the potential for measurement bias in cholesterol and liver function testing represents a risk-of-harm scenario that could affect patient clinical decisions.

Plain-English summary

Siemens Healthcare Diagnostics is recalling the Atellica CH LDL Cholesterol analyzer (Atellica CH 930) used in clinical laboratories. The device is an in vitro diagnostic system for quantitatively measuring LDL cholesterol and related analytes in human blood serum and plasma.

The recall is due to potential for reagent carryover on the analyzer that can result in a positive bias (falsely elevated results). This bias could affect patient samples, quality control samples, and calibration materials. The issue impacts measurement of LDL Cholesterol, Total Bilirubin, Gamma-Glutamyl Transferase (GGT), and HDL Cholesterol on the same device.

Approximately 6,733 units have been distributed nationwide in the United States and internationally to Taiwan, Uruguay, and Vietnam. All lot numbers of the device are included in this recall.

The recalled product

Product
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN): 11537214
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — Diagnostic Laboratory Analyzer
Hazard
  • reagent-carryover
  • analytical-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): 00630414611037 All Lot Numbers

Distribution

Distributed nationwide across the United States.

Related recalls

Same category