FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories Inc: 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.
- Recall number
- Z-1395-2009
- Recalling firm
- Bio-Rad Laboratories Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2008-12-09
- Posted
- 2009-05-19
- Terminated
- 2010-11-12
- Reason
- The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.
- Root cause
- Pending
- Action
- 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.
- Quantity
- 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 the UK.
- Lot, serial or model codes
- CDM version 4.0 software
- 510(k) numbers
- ["K063643"]
- PMA numbers
- not on file
- Product code
- LCP
- Firm FEI
- 2915274
- Firm city
- Hercules
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28