Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000, Manufactured by Bio-Rad Laboratories, Hercules, CA Measurement of percent hemoglobin Alc is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
- Company
- Bio-Rad Laboratories Inc
- Recall Initiated
- December 9, 2008
- Posted
- May 19, 2009
- Terminated
- November 12, 2010
- Recall Number
- Z-1395-2009
- Quantity
- 42 units
- Firm Location
- Hercules, CA
Reason for Recall
The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.
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 the UK.
Lot / Code Info
CDM version 4.0 software
Root Cause
Pending
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.