D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processi
FDA device recall Z-0695-2016 · posted 2016-01-27 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Reason for recall
- On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration.
- Action taken
- Urgent Medical Device Correction letters were sent on December 2015 to all affected consignees and subsidiaries. Each subsidiary will be given a Subsidiary Medical Device Correction Notice, Customer Medical Device Correction Notice, and Return Response Form and the number of customers distributed by e-mail. Each Subsidiary much contact customers and translate the Customer Medical Device Correction Notice and Return Response Form as needed. A revised letter to subsidiaries and customers was sent on January 20, 2016.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LCP
- Quantity affected
- 165 in US, 200 Internationally
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, Belgium, Brazil, Brunei Darussalam, China, Czech Republic, France, Germany, Greece, India, Israel, Italy, Malaysia, Maldi
- Date initiated
- 2015-12-15
- Date posted
- 2016-01-27
- Date terminated
- 2016-05-02
- Location
- Hercules, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM (K060001) | Bio-Rad Laboratories, Inc. | 2006-01-20 |