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Vitek 2 Gram Negative Piperacillin/Tazobactam

by Biomerieux, Inc.

510(k) K080107

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

100 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080107 Date28 Feb 2008ClearedStatusActive

Recalls

100 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2050-2011 FDA Unclassified (pre-2012) initiated 4 Apr 2011
    • Terminated Z-2049-2011 FDA Unclassified (pre-2012) initiated 4 Apr 2011

    The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.

  • 96 recalls, same reason

    • Terminated Z-0264-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0227-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0176-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0219-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0214-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0222-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0209-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0259-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0225-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0224-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0232-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0211-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0256-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0251-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0271-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0279-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0261-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0260-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0263-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0228-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0238-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0276-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0233-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0194-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0187-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0266-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0213-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0177-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0205-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0241-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0253-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0208-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0204-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0220-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0189-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0240-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0198-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0278-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0237-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0210-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0242-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0265-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0203-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0207-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0172-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0274-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0272-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0178-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0269-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0254-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0226-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0236-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0267-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0284-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0183-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0217-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0273-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0184-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0201-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0234-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0199-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0252-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0250-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0202-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0247-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0221-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0182-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0216-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0257-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0243-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0218-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0193-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0235-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0188-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0192-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0195-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0249-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0206-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0244-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0239-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0179-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0181-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0270-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0258-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0212-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0196-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0180-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0200-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0191-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0186-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0185-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0175-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0190-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0281-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0245-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010
    • Terminated Z-0280-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010

    AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.

    • Terminated Z-0277-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010

    The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptibility and false resistance results for E. coli; and the same drug is providing false susceptibility results for Klebsiella.

    • Terminated Z-0248-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010

    AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae..

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LON
Device Class
Class II
Regulation
21 CFR Part 866.1645
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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