FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
- Recall number
- Z-2041-2014
- Recalling firm
- Becton Dickinson & Co.
- Product
- BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
- Status
- Terminated
- Initiated
- 2014-05-21
- Posted
- 2014-07-11
- Terminated
- 2016-08-12
- Reason
- 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.
- Root cause
- Labeling mix-ups
- Action
- 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
- Quantity
- 18.210
- Distribution
- Worldwide Distribution - US (nationwide), Australia, Belgium, Canada, Colombia, China, Indonesia, India, Japan, Korea, Mexico, Malaysia, Peru, Philippines, Singapore, Thailand, and Taiwan.
- Lot, serial or model codes
- Lot. Number - 3224281 / Exp. Date - 2014/06/09 , Lot. Number - 3290379 / Exp. Date - 2014/07/24, Lot. Number - 3224281 / Exp. Date - 2014/06/09
- 510(k) numbers
- ["K926018"]
- PMA numbers
- not on file
- Product code
- JSS
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28