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U.S. Department of Health and Human Services

Class 3 Device Recall Kallestad (TM) HEp2

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 Class 3 Device Recall Kallestad (TM) HEp2see related information
Date Initiated by FirmJuly 29, 2008
Date PostedSeptember 19, 2008
Recall Status1 Terminated 3 on March 31, 2011
Recall NumberZ-2428-2008
Recall Event ID 49083
510(K)NumberK810863 
Product Classification Antimitochondrial Antibody - Product Code DBM
ProductKallestad (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.
Code Information Lot # and exp: For catalog # 30471: 951567, exp 2/28/09; 954479, exp 12/31/08; 954566, exp 11/30/08; 954895, exp 3/31/09; 955422, exp 2/28/09; 955495, exp 2/28/09; for catalog # 30472: 951564, exp 2/28/09; 954135, exp 2/28/09; 954481, exp 3/31/09; 954567, exp 3/31/09; 954858, exp 3/31/09; 954927, exp 3/31/09; 955197, exp 4/30/09; and for catalog # 32583: 951566, exp 2/28/09.
FEI Number 3022521
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories
6565 185th Ave NE
Redmond WA 98052-5039
For Additional Information ContactDaniel E Bennett
425-498-1805
Manufacturer 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 2		Employee error
ActionOn 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 Commerce4,400 total kits
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DBM
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