DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other hydroxylated metabolites in serum or plasma. REF: 68100E. DiaSorin Stillwater, Minnesota 55082-0285, U.S.A., Lot # 113300B.
FDA Recall Z-0705-05 · Posted 2005-04-13
Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeLCI
Date Initiated2004-06-30
Date Terminated2006-07-22
Product Quantity181
Reason for Recall
An incorrect expiration date of 2005/08/18 was placed on the kit box label for 25-hydroxyvitamin D [125I] RIA kits, Catalog 68100E, Lot 113300B. Correct label expiration date is 2004/08/18.
Firm Action
A customer notification letter was sent to customers 6/30/04. The letter identified theproduct, problem and the correct expiration date. Customers were instructed to complete the response form on the lower portion of the notification and fax it back to DiaSorin.
Root Cause
Other
Distribution Pattern
MI, IL, AZ, MN, OR, GA, MO, Sweden, Germany, Great Britain, Spain, Belgium, Italy, Norway, Brazil, Hungary, Switzerland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.