FDAClass IIJuly 10, 2019

ADVIA Chemistry Creatine Kinase recall

ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine…

Why was ADVIA Chemistry 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: 465336,465663,468449

Product
ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine…
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
3,386
Distribution
Worldwide distribution.
Recall date
July 10, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls