BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA Screen Agar)
FDA device recall Z-2608-2011 · posted 2011-06-21 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JTZ
- Quantity affected
- 5440 plates
- Distribution
- Worldwide Distribution--USA (nationwide) and the countries of Canada, Columbia, Jamaica, South Korea, and Taiwan.
- Date initiated
- 2011-04-20
- Date posted
- 2011-06-21
- Date terminated
- 2011-08-15
- Location
- Sparks, MD
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MUELLER HINTON AGAR W/4%NACL AND OXACILLIN (K863821) | Gibco Laboratories Life Technologies, Inc. | 1986-10-09 |