Z-0638-05

Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668

Name: Z-0638-05 Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668
Creator: Diasorin Inc.
Published: 2005-02-14
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2005-02-14 / Terminated / root cause: manufacturing process

FDA source

Diasorin Inc. began a recall of Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668 on 2005-02-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0638-05
Status: Terminated
Initiated: 2005-02-14
Posted: 2005-03-18
Terminated: 2006-07-22
Recalling firm: Diasorin Inc.
Product: Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668
Product code: MRG System, Test, Vitamin D
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 31 kits
Distribution: MA, Spain, Germany & Belgium
Product codes and lots: manufacturer part # 310900, Lot #114668

Product code MRG

K032844Class IILiaison 25 Oh Vitamin DDiaSorin, Inc. / cleared 2004-02-12

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)