Recall Z-0867-2010 ยท LCP Assay, Glycosylated Hemoglobin
Bio-Rad Laboratories Inc
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).
| Date | Feb 26, 2010 (initiated Oct 12, 2009) |
| Status | Terminated |
| Reason | Product update kit CD rom will not upload. As a result, the device cannot be run. |
| Root cause | Other |
| Action | 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 |
| Quantity | 21 kits |
| Distribution | Worldwide Distribution -- USA, Hong Kong, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063400 | VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 Bio-Rad Laboratories, Inc., Dec 1, 2006 |