Atellica CH Triglycerides_2 Reagent Recalled Due to Magnesium Test Interference
Siemens Healthcare Diagnostics is recalling 5,315 units of Atellica CH Triglycerides_2 diagnostic reagent due to reagent carryover that can affect magnesium test results. The product was distributed nationwide and internationally.
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 where reagent carryover affects the accuracy of critical chemistry test results. Although no illnesses have been reported, inaccurate magnesium measurements pose a risk of harm to patient care, meeting the severity rubric criterion for High severity as a risk-of-harm product.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 5,315 units of Atellica CH Triglycerides_2, an in vitro diagnostic reagent used with the Atellica CH Analyzer for the quantitative determination of triglycerides in human serum and plasma samples. All lots of this product are affected, identified by UDI 00630414610955.
The recall is due to reagent carryover from other tests performed on the Atellica CH Analyzer—specifically LDL Cholesterol Direct, Total Protein II, Triglycerides, and Triglycerides_2—which can interfere with the accuracy of magnesium measurement results.
The product has been distributed nationwide in the United States and internationally to multiple countries.
The recalled product
- Product
- Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithium heparin, sodium heparin, potassium EDTA) using the Atellica CH Analyzer. SMN: 11537222
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 5,315
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: 00630414610955 All Lots
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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