The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-2158-2019·Announced 2019-08-14

Polymer Technology Systems Recalls Mislabeled Lipid Panel Test Strips

Polymer Technology Systems is recalling 559 vials of IVD Lipid Panel test strips because the accompanying MEMo chips may be mislabeled, potentially causing the analyzer to display the wrong lot number.

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 by definition is unlikely to cause adverse health consequences. The issue is a labeling error on the MEMo chip rather than a defect in the test strips themselves.

Plain-English summary

Polymer Technology Systems, Inc. is recalling 559 vials of Henry Schein IVD Lipid Panel test strips, Reference Number 570-0414. The recall involves Lot P901, which has an expiration date of 8/17/2020. 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 was initiated because the MEMo chips provided with Lot P901 may be mislabeled. Specifically, the MEMo Chip may display "Q901" on the analyzer LCD screen instead of the correct lot number "P901". The MEMo Chip contains essential data, including the test name, calibration curve, lot number, and expiration date, which must be properly inserted into the analyzer before a test can be run.

The affected product was distributed worldwide, including in the US, Bahamas, Belgium, Bermuda, Brazil, England, Indonesia, Latvia, Mexico, Nigeria, Puerto Rico, South Africa, Sweden, and Taiwan. Users of these test strips should stop using Lot P901 and contact the manufacturer for further instructions.

The recalled product

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…
Manufacturer
Polymer Technology Systems, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
559

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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