Polymer Technology Systems, Inc.: 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

Is my product affected?

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 CardioChek Plus professional analyze

• UPC 00381931710016

Check against the official notice below — it lists the full affected range.

What happened

Polymer Technology Systems, Inc. is recalling PTS Panels Lipid Panel test strips (Reference Number 1710) used to measure total cholesterol and HDL levels. The recall affects lot P901 (expiration date 8/17/2020), which was distributed worldwide including across the United States, and impacted 1,887 vials in the US and 2,728 vials outside the US. The MEMo chips provided with this lot may be mislabeled and display "Q901" on the analyzer LCD screen instead of the correct lot designation "P901."

The source document does not specify what actions affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901

Details from the source

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 Distribution: Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan Quantity: 1,887 vials US; 2,728 vials OUS Lot/code info: Lot Number: P901 Exp. Date: 8/17/2020 (01) 00381931710016 (17) 200817 (10) P901

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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