510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-2429-2008

Kallestad (TM) Mouse Stomach/Kidney, catalog number 30443 - 8 wells, 48 tests. Product labeled "BIO-RAD...

Bio-Rad Laboratories Inc. / initiated 2008-07-29 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Bio-Rad Laboratories began a recall of Kallestad (TM) Mouse Stomach/Kidney, catalog number 30443 - 8 wells, 48 tests. Product labeled "BIO-RAD Kallestad (TM) Mouse Stomach/Kidney Substrate... UNITED... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2429-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Bio-Rad Laboratories Inc.
Product
Kallestad (TM) Mouse Stomach/Kidney, catalog number 30443 - 8 wells, 48 tests. Product labeled "BIO-RAD Kallestad (TM) Mouse Stomach/Kidney Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, 92430 Marnes La Coquette".
Product code
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
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.
Root cause tag
manufacturing process
FDA 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 Technical Support.
Quantity in commerce
2,568 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.
Product codes and lots
Lot # and exp: For number: 951562, exp 12/31/08; 953141, exp 1/31/09; 953242, exp 1/31/09; 953370, exp 1/31/09; 953402, exp 1/31/09; 953686, exp 1/31/09; 953687, exp 1/31/09; 953998, exp 1/31/09; 954045, exp 1/31/09; 954049, exp 1/31/09; 954226, exp 1/31/09; 954440, exp 1/31/09; 954441, exp 1/31/09; 954672, exp 3/31/09; 954711, exp 3/31/09; 954996, exp 3/31/09; 955096, exp 4/30/09; 955212, exp 4/30/09; 955314, exp 4/30/09; 955397, exp 4/30/09; and 955561, exp 4/30/09;