Z-1914-2010

GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 test kit)...

Name: Z-1914-2010 GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 test kit)...
Creator: Diasorin Inc.
Published: 2009-10-12
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2009-10-12 / Terminated / root cause: manufacturing process

FDA source

Diasorin Inc. began a recall of 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... on 2009-10-12. The reason FDA records is "The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1914-2010
Status: Terminated
Initiated: 2009-10-12
Posted: 2010-06-28
Terminated: 2012-04-17
Recalling firm: Diasorin Inc.
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.
Product code: CIB Radioimmunoassay, Angiotensin I And Renin
Reason for recall: The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 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.
Product codes and lots: Lot numbers: 123574A, 123612A, 123612C, 123620, 123620A, 123574, 123612, and 123612B.

Product code CIB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)