Recall Z-0109-2011 ยท LCP Assay, Glycosylated Hemoglobin
Bio-Rad Laboratories Inc
in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog 281-0001), manufactured by Bio-Rad Laboratories Deeside Ltd., Flintshire, UK, distributed by Bio-Rad Laboratories, Hercules, CA. The in2it (I) is for Physician use, the (II) is for prescription home use. The products are medical devices used in affinity chromatography method, intended for the in-vitro q
| Date | Oct 21, 2010 (initiated Sep 7, 2010) |
| Status | Terminated |
| Reason | Test Cartridges may leak and have the potential to generate error messages and biased inaccurate results. |
| Root cause | Component design/selection |
| Action | BIO-RAD Laboratories Deeside sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated September 7, 2010, via registered mail to all subsidiaries/customers. The letter described the product, problem and actions to be taken by the customer. The customers were instructed to stop using and discard the test cartridges from the listed lots; complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax +44 1244 833401; record the number of affected kits of product, confirm that they have discarded the cartridges and record the method of disposal. If you have any questions |
| Quantity | 4056 |
| Distribution | Worldwide distribution: USA and countries including: Australia, New Zealand, Taiwan, France, the UK, Singapore, Germany, Italy, Thailand, China, Korea, Sweden, Sri Lanka, Maldives, Canada and the Philippines. |
| 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 |