Recall Z-2430-2008
Bio-Rad Laboratories · initiated July 29, 2008
Product
Kallestad (TM) Mouse Kidney. Product labeled "BIO-RAD Kallestad (TM) Mouse Kidney Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, 92430 Marnes La Coquette". Catalog numbers: 30445 - 8 wells, 48 tests and 30447 - 8 well, 192 tests.
Codes / lots: Lot # and exp: for catalog # 30445 - 951563, exp 11/30/08; 953560, exp 1/31/09; and 955471, exp 4/30/09; for catalog # 30447 - 951565, exp 11/30/08; 953561, exp 1/31/09; and 954607, exp 3/31/09.
Reason for recall
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.
FDA-determined cause: Employee error
Action taken
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 Technical Support.
Details
- Recall number
- Z-2430-2008
- Initiated
- July 29, 2008
- Posted by FDA
- September 19, 2008
- Terminated
- March 31, 2011
- Product code
- DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- Quantity
- 69 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.
- Recalling firm
- Bio-Rad Laboratories, Redmond, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2428-2008 | Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2…The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128… | 07/29/2008Terminated |
| Z-2429-2008 | Kallestad (TM) Mouse Stomach/Kidney, catalog number 30443 - 8 wells, 48 tests. Product…The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128… | 07/29/2008Terminated |