The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-2157-2019·Announced 2019-08-14

PTS Lipid Panel Test Strips Recalled for MEMo Chip Labeling Error

Polymer Technology Systems is recalling Lipid Panel test strips because the included MEMo chips may display the wrong lot number on the analyzer screen.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a labeling error on the MEMo chip, which falls under the 'Low' severity criteria for documentation or packaging-only problems.

Plain-English summary

Polymer Technology Systems, Inc. is recalling PTS Panels Lipid Panel test strips, Reference Number 1710, Lot P901. The recall involves 1,887 vials in the United States and 2,728 vials outside the United States. These test strips are used with CardioChek PA or CardioChek Plus professional analyzers to measure total cholesterol, HDL cholesterol, and triglycerides in whole blood.

The recall is due to a labeling error on the MEMo chips provided with the test strips. The MEMo chip may display the lot number as Q901 on the analyzer's LCD screen instead of the correct lot number, P901. The MEMo chip contains the test name, calibration curve, lot number, and expiration date, and must be inserted into the analyzer before a test can be run.

The affected product was distributed worldwide, including in the United States, Bahamas, Belgium, Bermuda, Brazil, England, Indonesia, Latvia, Mexico, Nigeria, Puerto Rico, South Africa, Sweden, and Taiwan. The expiration date for the affected lot is August 17, 2020. Users should check their test strips for Lot P901 and contact the manufacturer for instructions on how to proceed.

The recalled product

Product
PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 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…
Manufacturer
Polymer Technology Systems, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Polymer Technology Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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