Device Recall HardyCHROM 0157 의 리콜

Recall

36309

Class 3

Z-0078-2007

2006-08-21

2006-10-27

Terminated

United States

2011-06-14

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48393

Performance failure; the product is failing to show pigment development for e. coli 0157.

Customers were first notified by phone on 8/21/06. Then all customers are faxed and mailed a signed recall letter via first class mail. All customers will be contacted, calling every few days until all have responded and all product reconciliation is made. A second recall notice was mailed 09/25/06 to include the original lot (#06192) plus an additional lot (#06235). Customers will be instructed to dispose of all remaining inventory. Hardy Diagnostics will credit or replace their purchase.