FDAClass IIIJuly 5, 2017

The Pointe Scientific CK-MB Isoenzyme Control Pointe recall: Labeling Error

The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit

Why was The Pointe Scientific CK-MB Isoenzyme Control Pointe recalled?

Incorrect control range in product labeling

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?

Model C7562-12 Control Kit. Lot: 013206-260, Expiration Date: 2013-03

Product
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Recalling firm
Medtest Holdings, Inc.
Quantity
5 kits
Distribution
FL, AR, NICARAGUA, KOREA
Recall date
July 5, 2017
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls