BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences C

FDA device recall Z-0976-2013 · posted 2013-03-22 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.

Action taken

BD Diagnostic Systems issued an Urgent Product Recall letter via UPS delivery on December 11, 2012. The letter identified the product, the problems, and the action to be taken by the customer. Customers were instructed to take the following actions: Discontinue and discard any affected product. BD would send replacements for the discarded material. Complete the attached form whether or not they have any inventory remaining so that the firm may acknowledge their receipt of the notification. Fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258 or Email to RegulatoryComplianceFax@BD.com.. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, contact BD Technical Services Department at 1-800-638-8663. The BD site in Belgium was notified via email. For questions regarding this recall call 410-316-4054.

Root cause

Process control

Status

Terminated

Product code

NJR

Quantity affected

27 boxes/648 cartridges

Distribution

Worldwide Distribution - USA including CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI and the country of Belgium

Date initiated

2012-12-11

Date posted

2013-03-22

Date terminated

2013-07-22

Location

Sparks, MD

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