Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Siemens Healthcare Diagnostics, Inc.
The hazard
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
UPC 00630414220505Would you have heard about this one?
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