Z-0536-2007

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

Name: Z-0536-2007 Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252
Creator: Diagnostic Chemicals, Ltd.
Published: 2006-09-06
License: https://open.fda.gov/license/

Sekisui Diagnostics P.E.I. Inc. / initiated 2006-09-06 / Terminated / root cause: labeling and UDI

FDA source

Diagnostic Chemicals, Ltd. began a recall of Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252 on 2006-09-06. The reason FDA records is "Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0536-2007
Status: Terminated
Initiated: 2006-09-06
Posted: 2007-02-27
Terminated: 2007-05-14
Recalling firm: Sekisui Diagnostics P.E.I. Inc.
Product: Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: 38 kits
Distribution: Nationwide.
Product codes and lots: Lot Number: 28423

Product code JIX

K042243Class IIMicroalbumin Multi-Calibrator SetDiagnostic Chemicals , Ltd. / cleared 2004-10-04

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)