Diagnostic test reagent may produce inaccurately low patient results
Siemens Healthcare's ADVIA Chemistry Microalbumin diagnostic test may produce falsely low results. Eight lots do not meet High-Dose Hook Effect and Prozone Effect specifications, potentially affecting microalbumin detection accuracy.
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 medical device with risk of inaccurate patient test results and potential for missed diagnoses, but no reported illnesses or injuries to date. Meets rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics is recalling eight lots of ADVIA Chemistry Microalbumin_2 diagnostic test reagent used to measure microalbumin in human urine samples. The affected lot numbers are 612528, 616644, 620971, 623768, 636498, 640513, 658356, and 668872, representing 19,645 units distributed worldwide, including throughout the United States.
The recalled test does not meet High-Dose Hook Effect and Prozone Effect specifications as described in the product's Instructions for Use. This means that when microalbumin levels are very high, the test may produce inaccurately depressed (low) results instead of accurate measurements.
Laboratory professionals using the identified lot numbers on Atellica CH, Atellica CI, ADVIA 1800, ADVIA 2400, or ADVIA Chemistry XPT analyzer systems should discontinue use of affected test reagent and contact Siemens Healthcare Diagnostics for replacement guidance.
The recalled product
- Product
- ADVIA Chemistry 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
- 19,645
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: 00630414517643 Lot Numbers: 612528
- 616644
- 620971
- 623768
- 636498
- 640513
- 658356
- 668872
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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