Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivatio

FDA device recall Z-0792-2013 · posted 2013-02-07 · Terminated

Recall details

Recalling firm

Diagnostic Hybrids Inc

Reason for recall

RhMK product fungal contamination.

Action taken

Diagnostic Hybrids sent a Urgent: Medical Device Recall letter dated December 31, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to immediately review your inventory and determine if you have any of the affected product. If so, please remove it from inventory. Complete the enclosed Product Recall Fax-Back form. Upon receipt of Fax-Back form, Diagnostic Hybrids will send you replacement product or issue credit. Representatives are available to assist you in this process and answer any questions you may have about this recall, and how to obtain replacement product. Please contact Technical Support at technicalsupport@quidel.com or by calling 800.874.1517, Monday through Friday, 8:00 a.m. to 5:00 p.m. EST.

Root cause

Process control

Status

Terminated

Product code

LKA

Quantity affected

13,005 units

Distribution

Nationwide Distribution including the states of AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA & WI.

Date initiated

2012-12-31

Date posted

2013-02-07

Date terminated

2013-12-05

Location

Athens, OH