Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA. Intended Use: For the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).

The firm initiated this action on 10/12/2009. Consignees were contacted by phone with a fax follow up. Subsidiaries, as well as consignees that received the product, were provided with a Medical Device Correction notice, dated October 13, 2009, and response form. Each subsidiary will contact customers. The letter asks customers to destroy the affected lot included with their reorder packs and replace them with the lot number that's enclosed. Customers are to complete the Customer Medical Device Correction Response Form and fax it to Bio-Rad CSD Regulatory Affairs Department at the number provided. Questions should be directed to customers' regional Bio-Rad office.