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

Recall Z-1741-2022 — PTS Panels CHOL+GLU Test Strips (REF 1765)

U.S. FDA — Device Enforcement · United States · 2022-08-16 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1741-2022
Date of alert
2022-08-16
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00381931765016
Reported risk: Incorrect instructions for use were packaged into the final product.
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.

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