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Terminated

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

FDA Recall Z-0638-05 · Posted 2005-03-18

Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeMRG
Date Initiated2005-02-14
Date Terminated2006-07-22
Product Quantity31 kits

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.

Firm 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.

Root Cause

Other

Distribution Pattern

MA, Spain, Germany & Belgium

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032844LIAISON 25 OH VITAMIN DDiaSorin, Inc. · 2004-02-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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