DCL (Diagnostic Chemicals Limited) Creatine Start Reagent(R1) Catalog Number: 265-OP.
FDA device recall Z-2327-2009 · posted 2009-09-30 · Terminated
Recall details
- Recalling firm
- Diagnostic Chemicals, Ltd.
- Reason for recall
- Labeled with extended expiration date (24 months instead of 18 months)
- Action taken
- 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
- Status
- Terminated
- Product code
- JFY
- Quantity affected
- 25 kits
- Distribution
- Worldwide Distribution -- United States (AL, CA, NJ, MO, PA, KY, FL, LA, MN, NY, NC, OH, TX and UT), Canada and Korea.
- Date initiated
- 2009-02-12
- Date posted
- 2009-09-30
- Date terminated
- 2012-05-23
- Location
- Charlottetown Canada, Prince Edward Island
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENZYMATIC CREATININE ASSAY (265 SERIES) (K070383) | Diagnostic Chemicals , Ltd. | 2007-06-22 |