Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2158-2019 — 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

U.S. FDA — Device Enforcement · United States · 2019-06-07 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2158-2019
Date of alert: 2019-06-07
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Polymer Technology Systems, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10304040037741

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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