Retiro De Equipo (Recall) de Device Recall HardyCHROM MRSA

Recall

71804

Class 2

Z-2463-2015

2015-07-09

2015-08-26

Terminated

United States

2015-11-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139127

Hardy diagnostics is recalling hardychrom mrsa due to a report of the potential for breakthrough of the methicillin-sensitive staphylococcus aureus (mssa) qc strain, atcc 29213 on the identified lot.

The firm initially notified customers via phone to inform them of a recall. The phone scripts asks customers if they have had any issued with the QC testing. The firm states that our of a precaution they are asking customers to discard the remaining plates of the identified lot, and that credit or replacement plates will be offered for any remaining. The firm followed-up phone calls with a written notification letter. The letter states to complete, sign, and fax or email back the enclosed form stating compliance with the above action. The letters states that is the customer could not be reached via phone and would like replacements or credit to contact the Customer Service Department at 800-266-2222, option 1. Any questions call the Technical Services Department at 800-266-2222, option 2 or email at techservice@hardy diagnostics.com.