Z-2326-2009

DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30. In-vitro diagnostic...

Name: Z-2326-2009 DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30. In-vitro diagnostic...
Creator: Diagnostic Chemicals, Ltd.
Published: 2009-02-12
License: https://open.fda.gov/license/

Sekisui Diagnostics P.E.I. Inc. / initiated 2009-02-12 / Terminated / root cause: labeling and UDI

FDA source

Diagnostic Chemicals, Ltd. began a recall of DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30. In-vitro diagnostic device used for the quantitative measurement of... on 2009-02-12. The reason FDA records is "Labeled with extended expiration date (24 months instead of 18 months)". 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-2326-2009
Status: Terminated
Initiated: 2009-02-12
Posted: 2009-09-30
Terminated: 2012-05-23
Recalling firm: Sekisui Diagnostics P.E.I. Inc.
Product: DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30. In-vitro diagnostic device used for the quantitative measurement of creatine in serum, plasma and urine.
Product code: JFY Enzymatic Method, Creatinine
Reason for recall: Labeled with extended expiration date (24 months instead of 18 months)
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Genzyme Corp. notified consignees by Letter dated February 12, 2009 via Federal Express. Accounts are requested to discontinue use and discard units. Customers were also asked to complete and sign the Confirmation of Notification the fax to 1-902-628-6504. For further information, contact Genzyme Technical Support at 1-800-565-0265.
Quantity in commerce: 82 kits
Distribution: Worldwide Distribution -- United States (AL, CA, NJ, MO, PA, KY, FL, LA, MN, NY, NC, OH, TX and UT), Canada and Korea.
Product codes and lots: Lot Numbers: 31895 Exp. March 09, 32120 Exp March 09, 32689 Exp Marh 09 and 32383 Exp May 09.

Product code JFY

K070383Class IIEnzymatic Creatinine Assay (265 Series)Diagnostic Chemicals , Ltd. / cleared 2007-06-22

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)