FDAClass IIJuly 10, 2019

Atellica CH Creatine Kinase recall

Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase…

Why was Atellica CH Creatine Kinase recalled?

A steady upward trend in blank (u) absorbance was observed

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Serial Numbers: 280765, 280766, 280767

Product
Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase…
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
899
Distribution
Worldwide distribution.
Recall date
July 10, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls