Martin-Lewis Agar Medium

• 2 recalls, same reason

  • Terminated Z-1377-2021 FDA Class II ·initiated 17 Mar 2021
  • Terminated Z-1378-2021 FDA Class II ·initiated 17 Mar 2021

  Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment

510(k) Number

K770287 ↗

FDA Product Code

JTY

Device Class

Class II

Regulation

21 CFR Part 866.2410

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Biphasic Blood Culture Bottle

  Class I

  FDA 510(k) K842036 Active Cleared 1 Jun 1984

• Pediatric Blood Culture Bottles

  Class I

  FDA 510(k) K810553 Active Cleared 20 Mar 1981

• Lombard Dowell Agar Base

  Class I

  FDA 510(k) K864014 Active Cleared 29 Oct 1986

• Gibco Mycotect Kit (Catalog No. 189-5672)

  Class I

  FDA 510(k) K860695 Active Cleared 12 Mar 1986

• Haemophilus Isolation Agar 2827

  Class I

  FDA 510(k) K841673 Active Cleared 21 May 1984

• Pre-Duced Culture Media

  Class I

  FDA 510(k) K770650 Active Cleared 15 Apr 1977

See all devices from Gibco Laboratories Life Technologies, Inc. →