GammaCoat 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.
FDA Recall Z-1914-2010 · Posted 2010-06-28
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Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeCIB
Date Initiated2009-10-12
Date Terminated2012-04-17
Product Quantity289 kits
Reason for Recall
The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range.
Firm Action
Consignees 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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