Sensititre Susceptibility Plates

• 9 recalls, same reason

  • Terminated Z-0329-2023 FDA Class I ·initiated 20 Oct 2022
  • Terminated Z-0332-2023 FDA Class I ·initiated 20 Oct 2022
  • Terminated Z-0331-2023 FDA Class I ·initiated 20 Oct 2022
  • Terminated Z-0333-2023 FDA Class I ·initiated 20 Oct 2022
  • Terminated Z-0327-2023 FDA Class I ·initiated 20 Oct 2022
  • Terminated Z-0328-2023 FDA Class I ·initiated 20 Oct 2022
  • Terminated Z-0334-2023 FDA Class I ·initiated 20 Oct 2022
  • Terminated Z-0335-2023 FDA Class I ·initiated 20 Oct 2022
  • Terminated Z-0330-2023 FDA Class I ·initiated 20 Oct 2022

  An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.

• • Terminated Z-2324-2009 FDA Unclassified (pre-2012) ·initiated 4 Jun 2009 ·on shared 510(k) K860753

  Thirty-one boxes of unapproved quarantine product, CP112-10 MHB w/LHB, Lot # 150444SA, were inadvertently shipped to customers on 6/2/09 instead of shipping approved Lot # 150344SA.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K860753 ↗

FDA Product Code

JWY

Device Class

Class II

Regulation

21 CFR Part 866.1640

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

• Martin-Lewis Agar Medium

  Class II

  FDA 510(k) K770287 Active Cleared 18 Feb 1977

• 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

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