Z-0181-2022 Class II Ongoing
FDA device recall Z-0181-2022 was initiated by Siemens Healthcare Diagnostics, Inc. on September 20, 2021 and is designated Class II. 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 Enzymati… The recall status is ongoing. Affected quantity: 246 (US); 689 (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- November 3, 2021
- Initiation Date
- September 20, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 246 (US); 689 (OUS)
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution.
Code Information
All lots impacted