Recall Z-2326-2009 ยท JFY Enzymatic Method, Creatinine
Diagnostic Chemicals, Ltd.
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.
| Date | Sep 30, 2009 (initiated Feb 12, 2009) |
| Status | Terminated |
| Reason | Labeled with extended expiration date (24 months instead of 18 months) |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070383 | ENZYMATIC CREATININE ASSAY (265 SERIES) Diagnostic Chemicals , Ltd., Jun 22, 2007 |