Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Reported: November 3, 2021 Initiated: September 20, 2021 #Z-0181-2022
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 246 (US); 689 (OUS)
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 246 (US); 689 (OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 3, 2021. Severity: Moderate. Recall number: Z-0181-2022.
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