BACTEC(tm) MGIT(tm) AST Starter Kit, Catalog 445941. Kit contains 16 each of the 5-Tube and 2-Tube Set Carriers. ***Bect

FDA device recall Z-2141-2011 · posted 2011-05-05 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

In vitro diagnostic device components are mislabeled.

Action taken

BD Diagnostic Systems sent an Urgent Product Recall letter on August 31, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter advised customers to discard any carriers or labels that contain the incorrect barcode for replacement. Accounts were requested to complete an attached reply form to acknowledge their receipt of the notification and fax it to 410-316-4258. For questions regarding this recall call BD Customer Service at 1-800-675-0908.

Root cause

Other

Status

Terminated

Product code

MJA

Quantity affected

4123 labels

Distribution

Worldwide Distribution - USA including CA, MA, MD, VA and the countries of Argentina, Colombia, Belgium, China, India, Hong Kong, Peru, Singapore, Thailand, and Trinidad.

Date initiated

2010-08-31

Date posted

2011-05-05

Date terminated

2011-07-08

Location

Sparks, MD