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

Recall Z-0929-2017 — Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

U.S. FDA — Device Enforcement · United States · 2016-07-20 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0929-2017
Date of alert: 2016-07-20
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Sterling Diagnostics, Inc.
Product category: device
Product type: Devices

Reported risk: Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.

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.

Recall Z-0929-2017 — Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

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