FDAClass IIApril 20, 2022

Atellica CH Calcium_2 recall

Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644

Why was Atellica CH Calcium_2 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: 00630414220697; Lot Numbers: 211392 211438 211484 211522 211526

Product
Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
2,395
Distribution
Global Distribution. US Nationwide.
Recall date
April 20, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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