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Terminated

BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Lot# 06136

FDA Recall Z-1451-06 · Posted 2006-08-29

Recalling FirmHardy Media Inc Dba Hardy Diag
Recall StatusTerminated
Product CodeJSO
Date Initiated2006-06-27
Date Terminated2011-06-14
Product Quantity860 plates

Reason for Recall

This recall is being conducted due to the performance failure nearing the end of the product shelf life.

Firm Action

Customers were first notified by phone on 6/28/06, then all customers were faxed and mailed a signed recall letter via first class mail.

Root Cause

Other

Distribution Pattern

Nationwide in AZ, CA, IA, ID, MI, MT, NC, & WY. Plus: Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964560BHI W/VANCOMYCIN AGARHardy Diagnostics · 1997-01-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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