Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Siemens Healthcare Diagnostics, Inc.
The hazard
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model All Lots within expiry/UDI: 00630414611099UPC 00630414611099Would you have heard about this one?
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