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Polymer Technology Systems, Inc. recalls Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS P
Recalled August 14, 2019 · FDA recall Z-2158-2019 · Polymer Technology Systems
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 · FDA Class III
Units
559 vials
Sold at
Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan
Description
The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
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.
Manufacturer(s)
Polymer Technology Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →