Z-1543-2018Class II

PTS Panels CHOL+GLU Test Strips (REF 1765)

Name: Z-1543-2018 PTS Panels CHOL+GLU Test Strips (REF 1765)
Creator: Polymer Technology Systems, Inc.
Published: 2018-03-14
License: https://open.fda.gov/license/

Polymer Technology Systems / initiated 2018-03-14 / Terminated

FDA source

Polymer Technology Systems, Inc. began a recall of PTS Panels CHOL+GLU Test Strips (REF 1765) on 2018-03-14. FDA classified it as Class II and gives the reason as "Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1543-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-14
Posted: 2018-04-28
Terminated: 2018-09-13
Recalling firm: Polymer Technology Systems
Product: PTS Panels CHOL+GLU Test Strips (REF 1765)
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)
FDA root cause: Under Investigation by firm
Action: Letters will be sent to each ship-to address, as well as each bill-to address via UPS with signature requirement. Customers will be instructed to immediately quarantine and destroy any materials remaining from these two lots.
Distribution: OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England
Product codes and lots: Lot # A705 UDI (01)00381931765016(17)180813(10)A705

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1543-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1543-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-28

Product code NBW

K041750Class IIPts Panels Chol+glu Test PanelPolymer Technology Systems, Inc. / cleared 2004-07-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)