Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro di

FDA device recall Z-0699-2013 · posted 2013-01-20 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification.

Action taken

Becton Dickinson initiated the recall by letter to direct accounts on 12/13/2012. Ex-US BD sites were notified via email, distributors were notified by fax and customer letters were delivered by UPS ground. The notification advised that the recalled kit contained citrate (CIT} and malonic acid (MLO} reagents in the reversed prong/well positions. Customers were advised to discontinue use of identified lot numbers and discard any remaining packages for replacements, and also to return the enclosed reply form. The recalling firm requested distributors to submit their customer list for direct BD notification to all end users. Contact the BD Customer Service Department at 1-800-638-8663 if further assistance is required.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

JSS

Quantity affected

67,820 units

Distribution

Worldwide Distribution-USA including the states of MA, TN, KY, IN, GA, NC, TX, NY, FL, AZ, WA, NJ, MI, and CA, and the countries of Uruguay, Taiwan, Singapore, Australia, South Korea, Mexico, Hong Kon

Date initiated

2012-12-13

Date posted

2013-01-20

Date terminated

2013-06-03

Location

Sparks, MD

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