White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent
FDA device recall Z-1103-2008 · posted 2008-05-14 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.
- Action taken
- Consignees were notified by a Product Recall letter sent 12/19/07. The letter instructs users to discontinue use of affected product and destroy any remaining inventory. Users were requested to return a customer reply form. For additional information, contact 1-877-4ABBOTT.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- GGK
- Quantity affected
- Product was distributed in the follow amounts: 1,199 botttles of lot code 51749i2; 1,150 bottles of lot code 1574i2, 1,150 bottles of lot code 56675i2
- Distribution
- Worldwide Distribution including USA states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI and
- Date initiated
- 2007-12-19
- Date posted
- 2008-05-14
- Date terminated
- 2008-07-02
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELL-DYN SAPPHIRE SYSTEM (K051215) | Abbott Laboratories | 2005-07-21 |
| ABBOTT CELL-DYN 4000 SYSTEM (K961439) | Abbott Diagnostics | 1996-10-18 |