BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for th

FDA device recall Z-2041-2014 · posted 2014-07-11 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates. A portion of these kits contain Crystal Inoculum fluid bottles that will expire prior to the date that was printed on the kit carton. The expiration date printed on the individual Crystal Inoculum fluid bottles is correct.

Action taken

BD Diagnostic sent an Urgent Product Recall letter dated May 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: Please discard any outer kit boxes that are labeled with the incorrect expiration date. All components of the kit will perform as expected with the expiration dates on each component. Our records indicate you may have been shipped a portion of the above-referenced product between August 23, 2013, and the present day. Please complete the attached form whether or not you have any inventory remaining so that we may acknowledge your receipt of this notification. It is not necessary to contact BD by telephone. Simply complete and fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258. If further assistance is needed, please contact the BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact the BD Technical Services Department at 1-800-638-8663. Please accept our apology for any inconvenience this may cause. BD is committed to providing you with the highest quality products. Thank you for your continued support. : -" / 06 . ;/ i )!.U fJJ aLA. Thierry Guilltrt Gail Claiborne Marketing / Regulatory Compliance

Root cause

Labeling mix-ups

Status

Terminated

Product code

JSS

Quantity affected

18.210

Distribution

Worldwide Distribution - US (nationwide), Australia, Belgium, Canada, Colombia, China, Indonesia, India, Japan, Korea, Mexico, Malaysia, Peru, Philippines, Singapore, Thailand, and Taiwan.

Date initiated

2014-05-21

Date posted

2014-07-11

Date terminated

2016-08-12

Location

Sparks, MD

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