FDA Medical Device Recalls (openFDA)
Diasorin Inc.: 25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.
- Recall number
- Z-1237-2007
- Recalling firm
- Diasorin Inc.
- Product
- 25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.
- Status
- Terminated
- Initiated
- 2007-08-21
- Posted
- 2007-09-20
- Terminated
- 2008-10-17
- Reason
- 25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer.
- Root cause
- Other
- Action
- Consignees were notified by phone on 8/21/07 followed by a written notification by Fax or email. The letter described the product and problem and recommended to inspect the kits and to destroy all tracer vials of lot number 726023. They also requested the consignee to return the findings by fax or mail.
- Quantity
- 117 kits
- Distribution
- Worldwide, including USA, CANADA, BRAZIL, INDIA, QATAR, SWEDEN, URUGUAY, ARGENTINA, and JORDAN.
- Lot, serial or model codes
- Part # 68100E, lot # 119604A
- 510(k) numbers
- ["K953567"]
- PMA numbers
- not on file
- Product code
- MRG
- 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