Z-0705-05

DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other...

Name: Z-0705-05 DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other...
Creator: Diasorin Inc.
Published: 2004-06-30
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2004-06-30 / Terminated / root cause: labeling and UDI

FDA source

Diasorin Inc. began a recall of DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other hydroxylated metabolites in serum or plasma. REF: 68100E... on 2004-06-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0705-05
Status: Terminated
Initiated: 2004-06-30
Posted: 2005-04-13
Terminated: 2006-07-22
Recalling firm: Diasorin Inc.
Product: 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.
Product code: LCI Automated Radioimmunoassay Systems, For Clinical Use
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.
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: 181
Distribution: MI, IL, AZ, MN, OR, GA, MO, Sweden, Germany, Great Britain, Spain, Belgium, Italy, Norway, Brazil, Hungary, Switzerland
Product codes and lots: Ref No. 68100E, Lot # 113300B.

Product code LCI

K983617Class I25-Hydroxyvitamin D 125I Ria KitDiaSorin, Inc. / cleared 1998-11-16

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)