Z-0741-2020Class II

PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus...

Name: Z-0741-2020 PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus...
Creator: Polymer Technology Systems, Inc.
Published: 2016-03-15
License: https://open.fda.gov/license/

Polymer Technology Systems / initiated 2016-03-15 / Terminated

FDA source

Polymer Technology Systems, Inc. began a recall of PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers on 2016-03-15. FDA classified it as Class II and gives the reason as "This lot of test strips is showing an under-recovery when tested against a reference method". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0741-2020
Classification: Class II
Status: Terminated
Initiated: 2016-03-15
Posted: 2019-12-26
Terminated: 2020-06-05
Recalling firm: Polymer Technology Systems
Product: PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: This lot of test strips is showing an under-recovery when tested against a reference method.
FDA root cause: Storage
Action: Customer Notification Letters dated 3/15/16 was sent to customers. Distributors were instructed to do the following: We need your assistance to communicate this information to any customers to whom you have shipped this specific lot of product. As per Quality System Regulations, you must have full traceability of medical product to the end-user. Please advise your customers to complete the Customer Acknowledgement and Notification Form so that PTS Diagnostics can document that they have received the notification. Upon receipt of the acknowledgement, PTS Diagnostics will provide replacements for any product which has not been consumed. Customers with any of this product remaining in their possession must Immediately discontinue use and dispose of their remaining inventory of PTS Panels CHOL+HOL+GLU test strips, lot number 1502. No other lots of this product or other PTS Diagnostics products are impacted by this action. PTS Diagnostics will provide appropriate replacement product for any product properly identified on the attached Customer Acknowledgement and Confirmation Form. Please immediately identify the number of remaining PTS Panels CHOL+HDL+GLU test strip vials you currently have remaining in inventory of lot 1502 on the attached form. We will supply you with replacement product for any unused inventory you have of this product and lot. Please return your completed form to PTS Diagnostics via fax at +1-317-870-5608 or via email at [email protected]. Customers were instructed to do the following: Customers with any of this product remaining in their possession must Immediately discontinue use and dispose of their remaining inventory of PTS Panels CHOL+HOL+GLU test strips, lot number 1502. No other lots of this product or other PTS Diagnostics products are impacted by this action. PTS Diagnostics will provide appropriate replacement product for any product properly identified on the attached Customer Acknowledgement and Confir
Quantity in commerce: 6467
Distribution: The products were distributed to the following US states: CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, and WI. The products were distributed to the following foreign countries: Australia, Belgium, Indonesia, Italy, Poland, South Africa, UK, and Vietnam.
Product codes and lots: Lot Number I502, UDI 00381932412018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0741-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0741-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-26

Product code NBW

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)