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.
FDA Recall Z-1041-2009 · Posted 2009-03-24
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Recalling FirmBio-Rad Laboratories Inc
Recall StatusTerminated
Product CodeLCP
Date Initiated2008-10-17
Date Terminated2010-11-12
Product Quantity92 units
Reason for Recall
Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.
Firm 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.
Root Cause
Pending
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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