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

Recall Z-1425-2021 — Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus speci

U.S. FDA — Device Enforcement · United States · 2021-03-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1425-2021
Date of alert: 2021-03-10
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Remel Inc
Product category: device
Product type: Devices

Reported risk: When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.

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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