CLASS II Device recall · Reported 9 May 2018 · FDA Enforcement Report

PTS Panels¿ CHOL+GLU Test Strips recalled by Polymer Technology Systems

Polymer Technology Systems is recalling PTS Panels¿ CHOL+GLU Test Strips (, distributed in 10 states. The recall was initiated on 14 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # A705 UDI (01)00381931765016(17)180813(10)A705

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1543-2018
FDA event ID: 79778
Recalling firm: Polymer Technology Systems, Indianapolis, IN
Classification: Class II
Status: Terminated
Recall initiated: 14 Mar 2018
FDA classified: 28 Apr 2018
Reported: 9 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Insulin Pumps & Glucose Monitors

Timeline

14 Mar 2018	Recall initiated by company
28 Apr 2018	Classified by FDA	+45 days
9 May 2018	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England

Florida Illinois Kentucky Minnesota New York Ohio Puerto Rico Tennessee Virginia Washington

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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