Siemens Atellica Microalbumin Diagnostic Test Kits Recalled for Measurement Error
Siemens Healthcare Diagnostics is recalling Atellica CH and ADVIA Chemistry Microalbumin test kits worldwide because they may not properly measure microalbumin in urine samples, potentially causing falsely low results that could delay diagnosis of kidney disease.
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 an FDA Class II recall with no reported hospitalizations or injuries. However, it involves a diagnostic test that may produce false-negative results (falsely low microalbumin), which meets the rubric criterion of 'risk-of-harm products where injury has not yet been reported' and warrants a High severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 18,483 units of Atellica CH Microalbumin_2 (ALB_2) and ADVIA Chemistry Microalbumin_2 (ALB_2) diagnostic test kits. These in vitro diagnostic tests are used to measure microalbumin in urine samples on Atellica CH, Atellica CI Analyzers, ADVIA 1800 Chemistry Systems, ADVIA 2400 Chemistry Systems, and ADVIA Chemistry XPT Systems.
The products do not meet their stated claims for eliminating the High-Dose Hook Effect and Prozone Effect, as specified in the Instructions for Use. As a result, the tests may produce erroneously depressed (falsely low) microalbumin measurements. This could lead to delayed diagnosis of kidney disease in patients being tested.
The affected lot numbers are 232033, 232128, 232137, 232146, 232147, 242149, 242150, and 242365. These have been distributed worldwide, including throughout the United States and approximately 70 other countries.
The recalled product
- Product
- Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 18,483
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 (8)
- UDI-DI: 00630414596310 Lot Numbers: 232033
- 232128
- 232137
- 232146
- 232147
- 242149
- 242150
- 242365
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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