Bio-Rad Laboratories 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Bio-Rad Laboratories
Lot Codes / Batch Numbers
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.
Products Sold
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.
Bio-Rad Laboratories is recalling Kallestad (TM) Mouse Kidney. Product labeled "BIO-RAD Kallestad (TM) Mouse Kidney Substrate... UNIT due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026