Recall Z-1395-2009 ยท LCP Assay, Glycosylated Hemoglobin
Bio-Rad Laboratories Inc
Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000, Manufactured by Bio-Rad Laboratories, Hercules, CA Measurement of percent hemoglobin Alc is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
| Date | May 19, 2009 (initiated Dec 9, 2008) |
| Status | Terminated |
| Reason | The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results. |
| Root cause | Pending |
| Action | Recall initiated on December 10, 2008. Notification conducted by phone call and fax for domestic consignees. Each subsidiary will receive the subsidiary Urgent: Medical Device Correction notice, customer medical device correction response form and number of customers distributed to by e-mail. Each subsidiary must contact customers and provide the customer notice and response form as needed. The notice stated that Bio-Rad Laboratories would release a follow up communication providing a permanent solution upon completion of an investigation. In the interim, it was recommended that customers |
| Quantity | 42 units |
| Distribution | Worldwide Distribution -- USA, Argentina, Australia, Brazil, Canada, China, Czech Republic, France, Germany, Hungary, India, Italy, Mexico, New Zealand, Singapore, South Korea, Sweden, Thailand, and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063643 | MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM Bio-Rad Laboratories Inc., Clinical Systems Divisi, Dec 27, 2006 |