Z-1327-2009

Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of...

Name: Z-1327-2009 Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of...
Creator: Diagnostic Chemicals, Ltd.
Published: 2008-03-14
License: https://open.fda.gov/license/

Sekisui Diagnostics P.E.I. Inc. / initiated 2008-03-14 / Terminated / root cause: manufacturing process

FDA source

Diagnostic Chemicals, Ltd. began a recall of Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of iron in serum on 2008-03-14. The reason FDA records is "Precipitate in product may cause elevated background absorbance interference". 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-1327-2009
Status: Terminated
Initiated: 2008-03-14
Posted: 2009-05-13
Terminated: 2012-05-16
Recalling firm: Sekisui Diagnostics P.E.I. Inc.
Product: Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of iron in serum.
Product code: JMO Ferrozine (Colorimetric) Iron Binding Capacity
Reason for recall: Precipitate in product may cause elevated background absorbance interference.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Genzyme Diagnostics P.E.I. Inc. notified the 1 account by a Removal Notification letter on 3/14/08 requesting that they stop using and discard any remaining stock. The customer is to request replacement through their normal channels. Questions or concerns should be directed to Penny White of Genzyme.
Quantity in commerce: 153 kits
Distribution: Nationwide Distribution
Product codes and lots: Lot Number: 33361 Exp: October 2010

Product code JMO

K961587Class IIron (Total) Assay Catalogue No. 102-10, 102-25Diagnostic Chemicals , Ltd. / cleared 1996-08-27

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)