Z-1373-2019Class II

CHOL+HDL+GLU test strips, REF 2412

Name: Z-1373-2019 CHOL+HDL+GLU test strips, REF 2412
Creator: Polymer Technology Systems, Inc.
Published: 2019-01-16
License: https://open.fda.gov/license/

Polymer Technology Systems / initiated 2019-01-16 / Terminated / root cause: design

FDA source

Polymer Technology Systems, Inc. began a recall of CHOL+HDL+GLU test strips, REF 2412 on 2019-01-16. FDA classified it as Class II and gives the reason as "Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1373-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-16
Posted: 2019-05-23
Terminated: 2020-06-24
Recalling firm: Polymer Technology Systems
Product: CHOL+HDL+GLU test strips, REF 2412
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed
Root cause tag: design
FDA root cause: Device Design
Action: The firm initially notified some of their customers from January through March 2019 with a Customer Bulletin. On March 28, 2019, the firm issued an updated Urgent Medical Device Recall letter to all affected customers. The letter alerted customers to the potential for test strips to slip out of the analyzer. Actions to be taken by the Customer/User: 1. Closely follow the instructions for proper testing. " Make sure the analyzer is sitting on a flat, stable surface. Do not perform testing with the analyzer held in the hand. " After inserting the test strip(s), do not move the analyzer until testing is complete and the test strip is removed. " As stated in the instructions for use, if an unexpected test result is given, the test should be repeated. There is no need to return or destroy the product. 2. Distributors should immediately forward this notice to all customers/users who may have received this product. 3. Acknowledge receipt of this instruction by completing the attached form, even if you do not have affected product on hand. If you have any questions, please contact Karmen Mercer, Director of Global Customer Care directly, Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time at +1 317-870-5610 or (U.S. toll-free) 877-570-8610.
Quantity in commerce: 67643 total
Distribution: Domestic distribution nationwide.
Product codes and lots: I808 I809 I811 I812 I814

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1373-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1371-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-23
Z-1372-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-23
Z-1373-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-23

Product code CGA

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)