Z-2158-2019Class III

Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414

Name: Z-2158-2019 Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414
Creator: Polymer Technology Systems, Inc.
Published: 2019-06-07
License: https://open.fda.gov/license/

Polymer Technology Systems / initiated 2019-06-07 / Terminated / root cause: labeling and UDI

FDA source

Polymer Technology Systems, Inc. began a recall of Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total... on 2019-06-07. FDA classified it as Class III and gives the reason as "The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2158-2019
Classification: Class III
Status: Terminated
Initiated: 2019-06-07
Posted: 2019-08-05
Terminated: 2020-07-08
Recalling firm: Polymer Technology Systems
Product: Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.
Product code: CHH Enzymatic Esterase--Oxidase, Cholesterol
Reason for recall: The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: PTS Diagnostic issued Medical Device Recall issued letter on June 7, 2019 via certified mail, letter provides reason for recall, health risk and action to take: Immediately check your inventories and, if you have further distributed this product, please identify the users and notify them at once of this product recall. 1. Immediately check your inventories and segregate any remaining materials from lot P901.2. Distributors should immediately forward this notice and response form 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.4. If you have remaining stock of lot P901, hold that stock in quarantine. Our Customer Care team will contact you to arrange for return of the materials.
Quantity in commerce: 559 vials
Distribution: Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan
Product codes and lots: Lot Number: P901 Exp. Date: 8/17/2020 (01) 10304040037741 (17) 200817 (10) P901

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2158-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2157-2019	Class III	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-05
Z-2158-2019	Class III	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-05

Product code CHH

K151545Class ICardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test SystemPolymer Technology Systems, Inc. / cleared 2016-12-22

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)