Z-2608-2011

BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA...

Name: Z-2608-2011 BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA...
Creator: Becton Dickinson & Co.
Published: 2011-04-20
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2011-04-20 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of... on 2011-04-20. The reason FDA records is "Oxacillin Screen Agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens". 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-2608-2011
Status: Terminated
Initiated: 2011-04-20
Posted: 2011-06-21
Terminated: 2011-08-15
Recalling firm: Becton Dickinson & Co
Product: BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus (MRSA). These strains are resistant to penicillinase-resistant penicillins (PRPs), such as methicillin, oxacillin and nafcillin. Since the method to detect MRSA uses the same inoculum as the Bauer-Kirby antimicrobial disc susceptibility test procedure, the oxacillin screen test may be conveniently performed on isolates at the same time as routine susceptibility testing.
Product code: JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Reason for recall: Oxacillin Screen Agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated April 2011 to all affected customers. The letter identifies the product, problem and actions to be taken by the customers. The letter instructed customers to discontinue use of the affected lot number and discard any remaining packages. Customers were requested to complete and return an attached response form via fax at 410-316-4258. The letter states that all discarded product will be replaced. Questions concerning the recall process were directed to BD Customer Service Department at 1-800-675-0908.
Quantity in commerce: 5440 plates
Distribution: Worldwide Distribution--USA (nationwide) and the countries of Canada, Columbia, Jamaica, South Korea, and Taiwan.
Product codes and lots: Lot 1034119 Exp. 2011/05/03

Product code JTZ

K863821Class IIMueller Hinton Agar W/4%nacl and OxacillinGibco Laboratories Life Technologies, Inc. / cleared 1986-10-09

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)