Siemens Atellica CH diagnostic reagent carryover may cause false laboratory test results
Siemens has recalled 18,524 units of its Atellica CH HDL Cholesterol diagnostic device due to potential reagent carryover that could produce false test results in patient samples and quality control testing.
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: FDA Class II classification for a laboratory diagnostic device with potential for false test results affecting patient samples and quality control testing. Meets the 'risk-of-harm products where injury has not yet been reported' severity criterion.
Plain-English summary
Siemens Healthcare Diagnostics is recalling 18,524 units of the Atellica CH HDL Cholesterol diagnostic device (Siemens Material Number 11537213, UDI 00630414610832) across all lot numbers. The device is an in vitro diagnostic used in clinical laboratories to measure HDL cholesterol levels in human blood samples.
The FDA has identified a potential for reagent carryover on the Atellica CH 930 analyzer. This carryover results in a positive bias—meaning falsely elevated readings—that could affect test results for HDL cholesterol, LDL cholesterol, bilirubin, and gamma-glutamyl transferase (GGT) measurements. The problem could impact both patient samples and quality control testing, as well as calibrator results.
The recalled devices have been distributed nationwide in the United States and internationally to Taiwan, Uruguay, and Vietnam.
The recalled product
- Product
- Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 18,524
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): 00630414610832 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.
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