FDAClass IIIJuly 5, 2017

Pointe Scientific Liquid Creatine Kinase Reagent Set recall

Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use…

Why was Pointe Scientific Liquid Creatine Kinase Reagent Set recalled?

Linear performance information in product insert does not match that listed in the approved premarket notification

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?

Models: C7522, HC422, HC722, HC922. Lot#'s: 020902; 029902 R1; 029902 R2; 029903; 113204; 129403; 209001. Exp dates 7/2012 to 9/2013.

Product
Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use…
Recalling firm
Medtest Holdings, Inc.
Quantity
319.922 L
Distribution
Nationwide Distribution
Recall date
July 5, 2017
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls