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U.S. Department of Health and Human Services

Class 3 Device Recall DiaSorin Lp(a) diluent

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 Class 3 Device Recall DiaSorin Lp(a) diluentsee related information
Date Initiated by FirmJanuary 10, 2005
Date PostedMarch 18, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall NumberZ-0636-05
Recall Event ID 31104
510(K)NumberK982708 
Product Classification Lipoprotein, Low-Density, Antigen, Antiserum, Control - Product Code DFC
ProductLp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03; 480 mL bulk catalog # 95046B, Lot # 238017-02. 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent Kits Catalog # 86084, Lot #s 1144332, 114432A,13656, 113656A, and 113656B for use in DiaSorin Antibody Reagent Set for Lp(a) SPQ Test System .
Code Information Lp(a) Diluent - 60 mL bottles Catalog #23817, Lot #s 238017-01 & 238017-03; catalog # 95046B, Lot # 238017-02. DiaSorin Lp(a) Antibody Reagent Kits Catalog # 86084, Lot #s 1144332, 114432A,113656, 113656A, and 113656B
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information ContactDiaSorin Technical Services
800-328-1482
Manufacturer Reason
for Recall		QC testing of the Antibody Reagent Set for Lp(a) SPQ Test System it was discovered that the background was failing high of the specification. Through substitution testing it was determined that the Lp(a) diluent, part #238017 was the cause of the failing background specification.
FDA Determined
Cause 2		Other
ActionCustomers were sent notification letters and instructed to destroy any remaining inventory. Customers were also requested to return a form which indicates number of kits destroyed and a replacement was offered.
Quantity in Commerce631 as individual vials, 1 bulk unit and 401 sold in kits
DistributionKC, MO, CA, IN, HI, GA, TX, MN, ME, AZ, FL, VA, MI, NJ, NC, NY, CO, WI, MS, BRUSSELS, GREECE, SWEDEN, ENGLAND, SPAIN, CANADA & SWITZERLAND
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 = DFC
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