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Terminated

Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252

FDA Recall Z-0536-2007 · Posted 2007-02-27

Recalling FirmDiagnostic Chemicals, Ltd.
Recall StatusTerminated
Product CodeJIX
Date Initiated2006-09-06
Date Terminated2007-05-14
Product Quantity38 kits

Reason for Recall

Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct

Firm Action

Diagnostic Chemicals Ltd, Canada notified customers by telephone and fax on 9/06/06 and advised to use the cap label to determine concentration of the calibrators. Accounts were asked to confirm and acknowledge receipt of the letter.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042243MICROALBUMIN MULTI-CALIBRATOR SETDiagnostic Chemicals , Ltd. · 2004-10-04

Official Source

View FDA Recall →

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

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