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

Recall Z-2192-2015 — HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.

U.S. FDA — Device Enforcement · United States · 2015-06-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2192-2015
Date of alert
2015-06-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Hardy Diagnostics
Product category
device
Product type
Devices
Reported risk: Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.
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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