CELL-DYN 3700 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assem
FDA device recall Z-2351-2010 · posted 2010-09-02 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.
- Action taken
- Product Recall letters were sent on 04/16/2010. The letters identified the affected product, explained the reason for recall, the patient impact/user safety, stated the necessary actions, and contact information. Users are to discontinue use until the Waste Chamber(s) have been replaced and follow the instructions in the Hazards section. In addition, appropriate protective equipment needs to be worn along with following their recommended laboratory procedures dealing with spills. Users are to contact their local Abbott Customer Support rep. US customers should be direct their questions to Customer Support.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 69 units total
- Distribution
- Worldwide Distribution -- CA, CT, ID, IN, and MA; and, countries of Australia, Brazil, Canada, China, Colombia, Mexico, Puerto Rico, Singapore, and Uruguay.
- Date initiated
- 2010-04-16
- Date posted
- 2010-09-02
- Date terminated
- 2010-12-06
- 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 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (K991605) | Abbott Laboratories | 1999-07-09 |