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Class 3 Device Recall Kallestad (TM) HEp2 |
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Date Initiated by Firm |
July 29, 2008 |
Date Posted |
September 19, 2008 |
Recall Status1 |
Terminated 3 on March 31, 2011 |
Recall Number |
Z-2428-2008 |
Recall Event ID |
49083 |
510(K)Number |
K810863
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Product Classification |
Antimitochondrial Antibody - Product Code DBM
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Product |
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. |
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. |
Recalling Firm/ Manufacturer |
Bio-Rad Laboratories 6565 185th Ave NE Redmond WA 98052-5039
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For Additional Information Contact |
Daniel E Bennett 425-498-1805
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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.
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FDA Determined Cause 2 |
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 |
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. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = DBM and Original Applicant = KALLESTAD LABORATORIES, INC.
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