CLASS II Device recall · Reported 30 Jan 2013 · FDA Enforcement Report

and Company, BBL Crystal Enteric/Nonfermenter ID Kit recalled

Becton Dickinson is recalling and Company, BBL Crystal Enteric/Nonfermenter ID Kit, distributed in 14 states. The recall was initiated on 13 Dec 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled67,820 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0699-2013
FDA event ID: 63958
Recalling firm: Becton Dickinson, Sparks, MD
Classification: Class II
Status: Terminated
Recall initiated: 13 Dec 2012
FDA classified: 19 Jan 2013
Reported: 30 Jan 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Insulin Pumps & Glucose Monitors

Timeline

13 Dec 2012	Recall initiated by company
19 Jan 2013	Classified by FDA	+37 days
30 Jan 2013	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Arizona California Florida Georgia Indiana Kentucky Massachusetts Michigan North Carolina New Jersey New York Tennessee Texas Washington

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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