Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which contains the update kit CD-ROM, Model/Catalog No.: 270-2423, Distributed and Manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA. Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).
FDA Recall Z-1342-2011 · Posted 2011-02-17
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Recalling FirmBio-Rad Laboratories Inc
Recall StatusTerminated
Product CodeLCP
Date Initiated2010-03-24
Date Terminated2011-03-04
Product Quantity48 units
Reason for Recall
The firm received customer complaints associated with the Update Kit CD-ROM not being able to generate a valid calibration after being uploaded, resulting in patient results not being generated.
Firm Action
Medical Device Correction letter dated March 24, 2010 was sent to customers. The letter identified the affected product and explained the reason for recall. Customers were asked to destroy Lot No. AA00190 and replace it with the Lot No. AA00838 CD-ROM that is enclosed with the letter. Customers are to complete and fax back the Medical Device Correction Response Form at the number provided.
Root Cause
Other
Distribution Pattern
Worldwide Distribution -- USA and Italy.
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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