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U.S. Department of Health and Human Services

Class 2 Device Recall GammaCoat Plasma Renin Activity 125 I RIA Kit

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 Class 2 Device Recall GammaCoat Plasma Renin Activity 125 I RIA Kitsee related information
Date Initiated by FirmOctober 12, 2009
Date PostedJune 28, 2010
Recall Status1 Terminated 3 on April 17, 2012
Recall NumberZ-1914-2010
Recall Event ID 53698
Product Classification Angiotensin I and Renin Radioimmunoassay - Product Code CIB
ProductGammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 test kit), DiaSorin, Stillwater, Minnesota 55082-0285. Indicated for the quantitative determination of plasma renin activity (PRA) by the radioimmunoassay of generated angiotension I.
Code Information Lot numbers: 123574A, 123612A, 123612C, 123620, 123620A, 123574, 123612, and 123612B.
FEI Number 2182595
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact
651-439-9710
Manufacturer Reason
for Recall		The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionConsignees were Emailed or faxed a "DiaSorin Customer Notification" letter dated October 21, 2009. The letter was addressed to "Dear Valued Customer". The letter described the Product name and the problem and provided the correct range for the Renin Activity Control provided with the kit. The letter also stated that replacement product for any previous failed runs. Customers are to complete the bottom portion of the letter and return it to the firm. Questions or concerns should be directed to DiaSorin Inc., Technical Services at 1-800-328-1482 or 651-439-9710.
Quantity in Commerce289 kits
DistributionWorldwide Distribution -- USA, including states of CA, CT, IN, LA, MI, NC, OH, TN, UT, and WA and countries of CANADA, BELGIUM, BRAZIL, INDIA, NORWAY, PORTUGAL, SPAIN, and SWEDEN.
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.
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