Recall Z-0122-2011 ยท LCP Assay, Glycosylated Hemoglobin
Bio-Rad Laboratories Inc
in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridges, for use with the in2it (I) and (II) self test system analyzer, manufactured by Bio-Rad, Flintshire, UK The in2it (I) and (II) is an affinity chromatography method and is intended for the in-vitro quantitative determination of A1c in capillary blood taken from a finger prick. The test is indicated for moni
| Date | Oct 22, 2010 (initiated Jul 26, 2010) |
| Status | Terminated |
| Reason | Inaccurate results with high bias-- Inaccurate results may be read by the machine, creating the risk for untreated hypoglycemia at elevated altitudes. |
| Root cause | Device Design |
| Action | BIO-RAD Laboratories Deeside Ltd., sent an URGENT: MEDICAL DEVICE CORRECTION letter, dated July 26, 2010, to their subsidiaries and to all customers identifying the product, the problem, and the action to be taken. Subsidiaries were to ensure that all customers received the letter with the Customer Medical Device Correction Response Form and collect the completed form from every customer. Once forms were received from all customers they were to be faxed to BIO-RAD Deeside Regulatory Affairs at +44 (0) 1244833401. Customers were instructed to run a test and visually inspect the test cartrid |
| Quantity | 90703 |
| Distribution | Product was distributed to Bio-Rad's US subsidiary, along with 18 other distribution subsidiaries outside the US. These distributed further to other consignees. POroduct was distributed to Mexico, Korea, Singapore, Italy, South Africa, India, Australia, Spain, Greece, France, Thailand, Germany, Ne |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041635 | G5 I HBA1C TEST, G5 II HBA1C TEST Provalis Diagnostics , Ltd., Aug 16, 2004 |