Atellica CH Fructosamine recall
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Why was Atellica CH Fructosamine recalled?
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
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?
UDI: 00630414595580; Lot Numbers: 211359 211451
- Product
- Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 199
- Distribution
- Global Distribution. US Nationwide.
- Recall date
- April 20, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)