Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrumen
FDA device recall Z-0701-2013 · posted 2013-01-22 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.
- Action taken
- Becton Dickinson sent an Urgent Field Corrective Action letter September 18, 2012,by fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that BD Field Service Associates will contact them within 7-10 days of the notification to determine if their instrument is impacted. Customers were requested to return a response form indicating the serial number on their instrument. If customers needed further assistance they were instrycted ti contact BD Technical Services Department at 1-800-638-8663. For questions regarding this recall call 410-316-4054.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NJR
- Quantity affected
- 86 Instruments
- Distribution
- USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI. Internationally to Canada, Europe and Japan.
- Date initiated
- 2012-09-18
- Date posted
- 2013-01-22
- Date terminated
- 2013-02-04
- 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 |
|---|---|---|
| BD MAX GBS ASSAY, BD MAX INSTRUMENT (K111860) | Becton, Dickinson & CO | 2012-02-16 |