FDA Medical Device Recalls (openFDA)
Diagnostic Chemicals, Ltd.: Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of iron in serum.
- Recall number
- Z-1327-2009
- Recalling firm
- Diagnostic Chemicals, Ltd.
- Product
- Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of iron in serum.
- Status
- Terminated
- Initiated
- 2008-03-14
- Posted
- 2009-05-13
- Terminated
- 2012-05-16
- Reason
- Precipitate in product may cause elevated background absorbance interference.
- Root cause
- Process control
- Action
- Genzyme Diagnostics P.E.I. Inc. notified the 1 account by a Removal Notification letter on 3/14/08 requesting that they stop using and discard any remaining stock. The customer is to request replacement through their normal channels. Questions or concerns should be directed to Penny White of Genzyme.
- Quantity
- 153 kits
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot Number: 33361 Exp: October 2010
- 510(k) numbers
- ["K961587"]
- PMA numbers
- not on file
- Product code
- JMO
- 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