Atellica CH Iron_2 Diagnostic Device Produces False Microalbumin Results from Reagent Carryover
Siemens Atellica CH Iron_2 in vitro diagnostic devices are being recalled because they produce falsely elevated microalbumin test results when a microalbumin test immediately follows an iron test. No illnesses have been reported.
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: This is a Class II medical device recall with no reported illnesses, injuries, or hospitalizations. The defect produces inaccurate laboratory test results that could affect medical decision-making, but no actual patient harm has been documented. Inaccurate diagnostic results represent a risk-of-harm, placing this recall at the High severity level.
Plain-English summary
Siemens Healthcare Diagnostics is recalling the Atellica CH Iron_2, an in vitro diagnostic device used to measure iron levels in blood samples. The device produces inaccurate microalbumin test results due to reagent carryover from the preceding iron test. The defect occurs only when a microalbumin test is performed immediately after an iron test.
The recall affects 1,614 units in the United States and 7,979 units in international markets. All lots of the device (UDI 00630414596402) are affected globally.
No illnesses or injuries have been reported in connection with this defect.
The recalled product
- Product
- Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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): 00630414596402 All lots
Distribution
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