Recall Z-1145-2010 ยท DHC System, Test, Systemic Lupus Erythematosus
Bio-Rad Laboratories Inc
BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. Positive Control included in lot is identified as "REF 425-2025" and "LOT CPM-591". in vitro diagnostic.
| Date | Mar 16, 2010 (initiated Jul 14, 2009) |
| Status | Terminated |
| Reason | The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863. |
| Root cause | Nonconforming Material/Component |
| Action | Bio-Rad initiated its field correction on July 14, 2009. The firm notified domestic consignees by phone followed by fax, and each subsidiary will be given an urgent notice, subsidiary response form, customer medical device correction notification, acknowledgement form and a listing of consignees. The subsidiaries must contact customers as instructed. |
| Quantity | 213 kits |
| Distribution | Worldwide distribution: USA, Australia, Canada, France, Italy, Korea, Mexico, Panama, Singapore, and Trinidad. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032868 | REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 Corgenix, Inc., Oct 14, 2003 |