Recall Z-2041-2014— Becton Dickinson & Co.

Name: FDA recall Z-2041-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-21

Class III · Terminated

Class III FDA medical device recall by Becton Dickinson & Co., initiated 2014-05-21, terminated 2016-08-12. It names one FDA 510(k) clearance: K926018. 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.. 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..

Recalling firm: Becton Dickinson & Co.
Classification: Class III
Status: Terminated
Initiated: 2014-05-21
Terminated: 2016-08-12
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K926018 — CRYSTAL ENTERIC/NONFERMENTER ID SYSTEMBecton Dickinson Microbiology Systems·cleared 1993-03-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.