BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group

FDA device recall Z-1422-2013 · posted 2013-05-29 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.

Action taken

BD Diagnostic Systems sent an Urgent Product Recall" letter dated April 2013 to all affected consignees and end users. The letter identified the affected product, problem and actions to be taken. The notice instructed consignees and end users to discontinue use of the products, discard remaining products, and return a completed response form. Consignees were requested to provide contact information for end users who received recalled product in distribution, to allow for recall notice. The letter included instructions to report injuries and/or illnesses to Medwatch, and address recall inquiries to BD Technical Services at 1-800-638-8663.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

JTO

Quantity affected

610 total test kits (PYR and Oxidase)

Distribution

Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.

Date initiated

0013-04-12

Date posted

2013-05-29

Date terminated

2013-09-28

Location

Sparks, MD