Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of iron in se
FDA device recall Z-1327-2009 · posted 2009-05-13 · Terminated
Recall details
- Recalling firm
- Diagnostic Chemicals, Ltd.
- Reason for recall
- Precipitate in product may cause elevated background absorbance interference.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JMO
- Quantity affected
- 153 kits
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-03-14
- Date posted
- 2009-05-13
- Date terminated
- 2012-05-16
- 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 |
|---|---|---|
| IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 (K961587) | Diagnostic Chemicals , Ltd. | 1996-08-27 |