Z-2324-2009

Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA...

Name: Z-2324-2009 Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA...
Creator: Trek Diagnostic Systems
Published: 2009-06-04
License: https://open.fda.gov/license/

Trek Diagnostic Systems, Ltd. / initiated 2009-06-04 / Terminated / root cause: manufacturing process

FDA source

Trek Diagnostic Systems began a recall of Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA. In vitro diagnostic products for clinical... on 2009-06-04. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2324-2009
Status: Terminated
Initiated: 2009-06-04
Posted: 2009-09-30
Terminated: 2010-02-26
Recalling firm: Trek Diagnostic Systems, Ltd.
Product: Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA. In vitro diagnostic products for clinical susceptibility testing of H. influenzae and Streptococcus spp., can provide both qualitative and quantitative results.
Product code: JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 6/4/2009 each customer was telephoned and instructed to immediately return the recall lot back to the firm. Replacement product was shipped.
Quantity in commerce: 31 boxes/10/11 ml tubes
Distribution: Nationwide Distribution -- PA, VA & WA.
Product codes and lots: Lot number 150444SA

Product code JTZ

K860753Class IISensititre Susceptibility PlatesGibco Laboratories Life Technologies, Inc. / cleared 1986-05-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)