HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/s

FDA device recall Z-2463-2015 · posted 2015-08-26 · Terminated

Recall details

Recalling firm

Hardy Diagnostics

Reason for recall

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.

Action taken

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.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

JSO

Quantity affected

2,820 (282 pk/10)

Distribution

Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD.

Date initiated

2015-07-09

Date posted

2015-08-26

Date terminated

2015-11-10

Location

Santa Maria, CA

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