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

Recall Z-2137-2018 — remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).

U.S. FDA — Device Enforcement · United States · 2018-05-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2137-2018
Date of alert: 2018-05-04
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Thermo Fisher
Product category: device
Product type: Devices

Reported risk: Product may fail performance testing for S aureus ATCC 43300.

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

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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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