FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2326-2009
- Recalling firm
- Diagnostic Chemicals, Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2009-02-12
- Posted
- 2009-09-30
- Terminated
- 2012-05-23
- 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.
- Lot, serial or model codes
- Lot Numbers: 31895 Exp. March 09, 32120 Exp March 09, 32689 Exp Marh 09 and 32383 Exp May 09.
- 510(k) numbers
- K070383
- PMA numbers
- not on file
- Product code
- JFY
- Firm FEI
- 3002806809
- Firm city
- Charlottetown Canada
- Firm state
- Prince Edward Island
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28