Diasorin Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
Lot numbers: 123574A, 123612A, 123612C, 123620, 123620A, 123574, 123612, and 123612B.
Products Sold
Lot numbers: 123574A, 123612A, 123612C, 123620, 123620A, 123574, 123612, and 123612B.
Diasorin Inc. is recalling GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 test kit) due to The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CT, IN, LA, MI, NC, OH, TN, UT, WA
Page updated: Jan 10, 2026