Recall Z-0181-2022— Siemens Healthcare Diagnostics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2021-09-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151. Reason: The firm has confirmed the potential for ADVIA Chemistry 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..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-09-20
- Firm location
- Tarrytown, NY, United States
Product description
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Reason for recall
The firm has confirmed the potential for ADVIA Chemistry 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.