CLASS III Device recall · Reported 23 Jul 2014 · FDA Enforcement Report
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification recalled
Becton Dickinson & is recalling BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, distributed nationwide in the US. The recall was initiated on 21 May 2014 and the FDA has classified it as Class III.
Check your package
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-2041-2014
- FDA event ID
- 68468
- Recalling firm
- Becton Dickinson &, Sparks, MD
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 May 2014
- FDA classified
- 11 Jul 2014
- Reported
- 23 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 21 May 2014 | Recall initiated by company | |
| 11 Jul 2014 | Classified by FDA | +51 days |
| 23 Jul 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US (nationwide), Australia, Belgium, Canada, Colombia, China, Indonesia, India, Japan, Korea, Mexico, Malaysia, Peru, Philippines, Singapore, Thailand, and Taiwan.
Questions about this recall
Is BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System recalled?
Yes. Becton Dickinson & recalled BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System on 21 May 2014. The recall is Class III and its status is Terminated. Recall number Z-2041-2014.
Why was it recalled?
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.
Which lots are affected?
Lot. Number - 3224281 / Exp. Date - 2014/06/09 , Lot. Number - 3290379 / Exp. Date - 2014/07/24, Lot. Number - 3224281 / Exp. Date - 2014/06/09
Where was it sold?
Worldwide Distribution - US (nationwide), Australia, Belgium, Canada, Colombia, China, Indonesia, India, Japan, Korea, Mexico, Malaysia, Peru, Philippines, Singapore, Thailand, and Taiwan.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 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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