BD MAX DNA Extraction Kit DNA-3 (Swabs in Transport Medium/UTM), Catalog Number 437503. Kit contains 24/2D barcode sampl

FDA device recall Z-3218-2011 · posted 2011-09-16 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

Sample results maybe switched between time it was scanned with handheld barcode reader and time it was placed in the sample rack, associating sample results to wrong patient.

Action taken

BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated May 2011, to all affected customers. The letter identified the products, the problem, and the action to be taken by the customers. The letter advised customers to discontinue use of the Sample Preparation Reagent tubes in the referenced kits and discard any remaining products. Customers were requested to complete an attached reply form to acknowledge their receipt of the notification and fax it to (410) 316-4258. For further assistance regarding replacements contact BD Customer Service Dept. 1-800-675-0908. For all other inquiries, contact BD Technical Services Dept. 1-800-638-8663.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NQX

Quantity affected

163 kits

Distribution

Worldwide Distribution-USA (nationwide) including the states of CA, KY, MD, MI, NC, NY, TX, and WI and the country Belgium.

Date initiated

2011-05-24

Date posted

2011-09-16

Date terminated

2011-10-12

Location

Sparks, MD