Crystal Enteric/Nonfermenter Id System

• • Terminated Z-2041-2014 FDA Class III ·initiated 21 May 2014

  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.

• • Terminated Z-0699-2013 FDA Class II ·initiated 13 Dec 2012

  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.

510(k) Number

K926018 ↗

FDA Product Code

JSS

Device Class

Class I

Regulation

21 CFR Part 866.2660

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Gcii Agar with Isovitalx(R) Enrichment

  Class II

  FDA 510(k) K945569 Active Cleared 2 Feb 1995

• Fosfomycin, 200 Mg, Sensi-Disc

  Class II

  FDA 510(k) K972098 Active Cleared 28 Jul 1997

• Meropenem, 10 Mcg, Sensi-Disc Open recall

  Class II

  FDA 510(k) K963845 Active Cleared 25 Oct 1996

• Enterococcus Screening Medium

  Class II

  FDA 510(k) K951539 Active Cleared 13 Jun 1995

• Sparflozacin, 5 Mcg, Sensi-Disc

  Class II

  FDA 510(k) K970385 Active Cleared 10 Mar 1997

• Gc II Agar with Isovitalex

  Class II

  FDA 510(k) K932882 Active Cleared 24 Sep 1993

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