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Recall Observatory FDA recall evidence

Device product

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543

Z-0180-2022

September 20, 2021

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 88784
Status
Ongoing
Classification
Class II
Quantity
1402 (US); 2941 (OUS)
Official record key
device-enforcement:Z-0180-2022

Official wording

Reason: The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.

Code information: All lots impacted

Distribution pattern: Worldwide distribution - US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.