Polymer Technology Systems, Inc.: 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 cholester

Is my product affected?

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 profess

• UPC 10304040037741

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

What happened

Polymer Technology Systems, Inc. is recalling Henry Schein Panels Lipid Panel test strips (Ref Number: 570-0414) used to measure total cholesterol. The recall affects Lot Number P901 (expiration date 8/17/2020), which consisted of 559 vials distributed worldwide including the United States, Bahamas, Belgium, Bermuda, Brazil, England, Indonesia, Latvia, Mexico, Nigeria, Puerto Rico, South Africa, Sweden, and Taiwan. The MEMo chips provided with this lot may be mislabeled and could display "Q901" on the analyzer LCD screen instead of "P901."

The source document does not specify a remedy or recommended action for affected consumers.

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: 559 vials Lot/code info: Lot Number: P901 Exp. Date: 8/17/2020 (01) 10304040037741 (17) 200817 (10) P901

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• 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 analyze2019-06-07
• Powerheart¿ G5 Automatic AED2019-06-04
• BrightView SPECT, Model Number 8824802019-06-10
• SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of barbiturates in human urine a2019-06-12
• ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to enc2019-06-12

All FDA (Device enforcement) recalls