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

Recall Z-0216-2016 — ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250: TRIGLYCERIDES SL, CRSL-025

U.S. FDA — Device Enforcement · France · 2015-09-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0216-2016
Date of alert: 2015-09-22
Country / jurisdiction: France
Risk level: Class II
Risk type: recall
Brand: ELITech Clinical Systems SAS
Product category: device
Product type: Devices

Reported risk: ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM systems are recalled due to potential drug interference. No complaints were received.

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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