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.
FDA Recall Z-2326-2009 · Posted 2009-09-30
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Recalling FirmDiagnostic Chemicals, Ltd.
Recall StatusTerminated
Product CodeJFY
Date Initiated2009-02-12
Date Terminated2012-05-23
Product Quantity82 kits
Reason for Recall
Labeled with extended expiration date (24 months instead of 18 months)
Firm 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.
Root Cause
Labeling Change Control
Distribution Pattern
Worldwide Distribution -- United States (AL, CA, NJ, MO, PA, KY, FL, LA, MN, NY, NC, OH, TX and UT), Canada and Korea.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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