BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P/N: 340166, Product is manufac
FDA device recall Z-1007-2010 · posted 2010-04-16 · Terminated
Recall details
- Recalling firm
- BD Biosciences, Systems & Reagents
- Reason for recall
- The product is mislabeled, in that, zero/low controls were mislabeled as medium/high, and the medium/high controls were labeled zero/low.
- Action taken
- On 1/29/09, the firm initiated the recall and its notification was via Important Product Information letters identifying the affected product and explaining the reason for the recall. Customers who experienced error codes with the affected product were to contact their local BD Biosciences representative or distributor to receive replacement BD FACSCount controls.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 17 units
- Distribution
- Nationwide Distribution -- Including states of WA, MO, NV, CA, NY, PA, AL, and OR.
- Date initiated
- 2009-01-29
- Date posted
- 2010-04-16
- Date terminated
- 2011-03-08
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 (K081213) | Bd Biosciences | 2008-08-14 |
| FASCOUNT SYSTME (K933486) | Becton Dickinson Immunocytometry Systems | 1994-09-09 |