Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000, Manufactured by Bio-Rad Laboratories
FDA device recall Z-1395-2009 · posted 2009-05-19 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories Inc
- Reason for recall
- The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.
- Action taken
- Recall initiated on December 10, 2008. Notification conducted by phone call and fax for domestic consignees. Each subsidiary will receive the subsidiary Urgent: Medical Device Correction notice, customer medical device correction response form and number of customers distributed to by e-mail. Each subsidiary must contact customers and provide the customer notice and response form as needed. The notice stated that Bio-Rad Laboratories would release a follow up communication providing a permanent solution upon completion of an investigation. In the interim, it was recommended that customers carefully review the Summary Report for duplicate barcode IDs or or tube position numbers within the same rack. If there are any questions or assistance needed, the local regional Bio-Rad office should be contacted.
- Root cause
- Pending
- Status
- Terminated
- Product code
- LCP
- Quantity affected
- 42 units
- Distribution
- Worldwide Distribution -- USA, Argentina, Australia, Brazil, Canada, China, Czech Republic, France, Germany, Hungary, India, Italy, Mexico, New Zealand, Singapore, South Korea, Sweden, Thailand, and t
- Date initiated
- 2008-12-09
- Date posted
- 2009-05-19
- Date terminated
- 2010-11-12
- 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 |
|---|---|---|
| MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM (K063643) | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2006-12-27 |