FDAClass IIMay 9, 2018

PTS Panels¿ CHOL+GLU Test Strips recall

PTS Panels¿ CHOL+GLU Test Strips (REF 1765)

Why was PTS Panels¿ CHOL+GLU Test Strips recalled?

Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)

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?

Lot # A705 UDI (01)00381931765016(17)180813(10)A705

Product
PTS Panels¿ CHOL+GLU Test Strips (REF 1765)
Recalling firm
Polymer Technology Systems, Inc.
Quantity
N/A
Distribution
OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England
Recall date
May 9, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls