Z-0699-2013Class II

Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits...

Name: Z-0699-2013 Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits...
Creator: Becton Dickinson & Co.
Published: 2012-12-13
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2012-12-13 / Terminated

FDA source

Becton Dickinson & Co. began a recall of Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological... on 2012-12-13. FDA classified it as Class II and gives the reason as "In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0699-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-13
Posted: 2013-01-20
Terminated: 2013-06-03
Recalling firm: Becton Dickinson & Co
Product: Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is 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.
Product code: JSS Kit, Identification, Enterobacteriaceae
Reason for recall: In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification.
FDA root cause: Mixed-up of materials/components
Action: Becton Dickinson initiated the recall by letter to direct accounts on 12/13/2012. Ex-US BD sites were notified via email, distributors were notified by fax and customer letters were delivered by UPS ground. The notification advised that the recalled kit contained citrate (CIT} and malonic acid (MLO} reagents in the reversed prong/well positions. Customers were advised to discontinue use of identified lot numbers and discard any remaining packages for replacements, and also to return the enclosed reply form. The recalling firm requested distributors to submit their customer list for direct BD notification to all end users. Contact the BD Customer Service Department at 1-800-638-8663 if further assistance is required.
Quantity in commerce: 67,820 units
Distribution: Worldwide Distribution-USA including the states of MA, TN, KY, IN, GA, NC, TX, NY, FL, AZ, WA, NJ, MI, and CA, and the countries of Uruguay, Taiwan, Singapore, Australia, South Korea, Mexico, Hong Kong, Guatemala, Colombia, Chile, Canada, India, Japan, Brazil, China and Belgium.
Product codes and lots: Lot Number/ Exp Date 2086315 February 20, 2013 2101435 February 20, 2013 2104316 February 27, 2013 2129460 February 27, 2013 2129487 March 13, 2013 2163211 February 27, 2013 2163213 March 20, 2013 2163215 March 27, 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0699-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0699-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-19

Product code JSS

K926018Class ICrystal Enteric/nonfermenter Id SystemBecton Dickinson Microbiology Systems / cleared 1993-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)