The Recall Desk
HighFDA (Devices)·Z-1270-2023·Announced 2023-09-06

Atellica CH Triglycerides Diagnostic Kit Recalled for Reagent Carryover

Siemens Healthcare Diagnostics is recalling 11,824 units of Atellica CH Triglycerides test kits due to reagent carryover from other test parameters that can affect magnesium measurement accuracy. The FDA classified this as a Class II recall.

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: FDA Class II medical device recall involving diagnostic test accuracy. The hazard presents a confirmed risk of incorrect test results that could affect diagnostic reliability, but no illnesses or injuries have been reported. This meets the criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 11,824 units of Atellica CH Triglycerides (concentrated) diagnostic test kits. These in vitro diagnostic tests are designed to measure triglyceride levels in human serum and plasma samples using the Atellica CH Analyzer.

The recall was initiated because reagent carryover from multiple test parameters—LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2)—can affect the accuracy of magnesium measurement results. This carryover may lead to incorrect test outcomes.

The affected test kits were distributed nationwide and internationally to more than 50 countries, including Canada, Mexico, the United Kingdom, France, Germany, Japan, China, and Australia. The FDA classified this as a Class II recall (recall number Z-1270-2023).

The recalled product

Product
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma (lithium heparin, potassium EDTA) using the Atellica CH Analyzer SMN: 11097591
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostic Test
Hazard
  • reagent-carryover
  • inaccurate-results

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)

  • UDI: 00630414596495 All Lots

Distribution

Distributed nationwide across the United States.

Related recalls

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