GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 test kit), DiaSorin, Stillwat
FDA device recall Z-1914-2010 · posted 2010-06-28 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CIB
- Quantity affected
- 289 kits
- 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.
- Date initiated
- 2009-10-12
- Date posted
- 2010-06-28
- Date terminated
- 2012-04-17
- Location
- Stillwater, MN
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