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.
- Company
- Diasorin Inc.
- Recall Initiated
- October 12, 2009
- Posted
- June 28, 2010
- Terminated
- April 17, 2012
- Recall Number
- Z-1914-2010
- Quantity
- 289 kits
- Firm Location
- Stillwater, MN
Reason for Recall
The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range.
Distribution
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.
Lot / Code Info
Lot numbers: 123574A, 123612A, 123612C, 123620, 123620A, 123574, 123612, and 123612B.
Root Cause
Nonconforming Material/Component
Action Taken
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.