FDA Medical Device Recalls (openFDA)
Diasorin Inc.: Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668
- Recall number
- Z-0638-05
- Recalling firm
- Diasorin Inc.
- Product
- Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668
- Status
- Terminated
- Initiated
- 2005-02-14
- Posted
- 2005-03-18
- Terminated
- 2006-07-22
- Reason
- An internal inspection indicates that Calibrator 2 and Conjugate are switched in their positions in the integral. This will result in Calibrator 1 RLU's similar to that of background RLU, and Calibrator 2 RLU's near expected range. A curve can not be calculated from this data.
- Root cause
- Other
- Action
- DiaSorin Customer Notification dated 02/14/05 was sent to customers instructing them to destroy all kits from the affected lot number. Customers were also asked to complete and return a form indicating how many kits were destroyed.
- Quantity
- 31 kits
- Distribution
- MA, Spain, Germany & Belgium
- Lot, serial or model codes
- manufacturer part # 310900, Lot #114668
- 510(k) numbers
- ["K032844"]
- 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