FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories Inc: Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by Bio-Rad Laboratories, Hercules, CA Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. This device only tests for A 1 c.
- Recall number
- Z-1041-2009
- Recalling firm
- Bio-Rad Laboratories Inc
- Product
- Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by Bio-Rad Laboratories, Hercules, CA Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. This device only tests for A 1 c.
- Status
- Terminated
- Initiated
- 2008-10-17
- Posted
- 2009-03-24
- Terminated
- 2010-11-12
- Reason
- Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.
- Root cause
- Pending
- Action
- An Urgent Medical Device Correction letter was sent out on October 17, 2008 via fax and phone call. The letter recommended that customers review the Summary Report for duplicate tube position numbers or barcode IDs within the same rack. If there are questions or a need for assistance, customers are to contact their regional Bio-Rad office. Follow-ups will be made once root cause is identified.
- Quantity
- 92 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- version 4.0 software
- 510(k) numbers
- ["K063400"]
- 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