Recall Z-2428-2008 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Bio-Rad Laboratories
Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2 Cell Line Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, 92430 Marnes La Coquette". Catalog #: 30471 - 12 well kit, 60 tests; 30472 - 12 well kit, 240 tests; and 32583 - 6 well kit, 48 tests.
| Date | Sep 19, 2008 (initiated Jul 29, 2008) |
| Status | Terminated |
| Reason | The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit. |
| Root cause | Employee error |
| Action | On 7/25/08, the firm began to notify their customers about the recall via an Urgent Product Correction sent by DHL or FEDEX. Included with the customer letter was a revised QC Card. International subsidiaries were notified by e-mail with the customer letter and revised QC Card attached. The letter informed customers of the recall and directing them to the revised QC card which was attached to the letter. The instructions are to, "Please use this to replace the card in any kits remaining in your facility." If customers have any questions or require additional QC cards, they are to contact |
| Quantity | 4,400 total kits |
| Distribution | Worldwide Distribution --- including USA and countries of AUSTRALIA, BRAZIL, CANADA, CHINA , FRANCE, GERMANY, HONG KONG, INDIA, ITALY, JAPAN, MEXICO, NEW ZEALAND, POLAND, SINGAPORE, SOUTH KOREA , TAIWAN, UNITED KINGDOM, and URUGUAY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K810863 | KALLESTAD HEP-2 CELL LINE SUBSTRATE Kallestad Laboratories, Inc., Apr 14, 1981 |