bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument The product is most commonly used to

FDA device recall Z-0318-2013 · posted 2012-11-16 · Terminated

Recall details

Recalling firm

Biomerieux Inc

Reason for recall

The product may mislabel patient information on culture specimen bottles due to a software miscommunication.

Action taken

BIOMERIEUX sent an Urgent Product Correction Notice to all affected customers starting on October 16, 2012, The letter identified the affected product, the problem, and the action to be taken by hte customer. The firm provided modified instructions for use to clarify how to properly load bottles and to provide appropriate cautions and warnings concerning bottle loading. Customers were instructed to ensure that the letter and guidance on how to properly scan and load bottles is distributed, and training is provided to all appropriate personnel within their organization. Check for lost bottles in their system; fill out and return the Acknowledgement Form in Attachment A by fax to confirm receipt of the notice. Customers were instructed to contact their local bioMerieux Customers Service Representative with any questions. For questions regarding this recall call 919-620-2682.

Root cause

Software design

Status

Terminated

Product code

MDB

Quantity affected

2 modules

Distribution

Worldwide Distribution - USA including AR, AZ, CA, FL, KS, LA, MD, MN, MT, NC, NV, NY, OR, PA, RI, SC, TX, VA and WA. Internationally to Argentina, Armenia, Austria, Bangladesh, Bosnia and Herzegowina

Date initiated

2012-10-16

Date posted

2012-11-16

Date terminated

2013-10-28

Location

Hazelwood, MO