FDA Medical Device Recalls (openFDA)
Diasorin Inc.: 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.
- Recall number
- Z-0705-05
- 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.
- Status
- Terminated
- Initiated
- 2004-06-30
- Posted
- 2005-04-13
- Terminated
- 2006-07-22
- Reason
- 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
- 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
- 181
- Distribution
- MI, IL, AZ, MN, OR, GA, MO, Sweden, Germany, Great Britain, Spain, Belgium, Italy, Norway, Brazil, Hungary, Switzerland
- Lot, serial or model codes
- Ref No. 68100E, Lot # 113300B.
- 510(k) numbers
- ["K983617"]
- PMA numbers
- not on file
- Product code
- LCI
- Firm FEI
- 2182595
- Firm city
- Stillwater
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28