Atellica CH Urinary/Cerebrospinal Fluid Protein recall
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Why was Atellica CH Urinary/Cerebrospinal Fluid Protein recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots impacted
- Product
- Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1402 (US); 2941 (OUS)
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Recall date
- November 3, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)