Recall Z-1327-2009 ยท JMO Ferrozine (Colorimetric) Iron Binding Capacity
Diagnostic Chemicals, Ltd.
Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of iron in serum.
| Date | May 13, 2009 (initiated Mar 14, 2008) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961587 | IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 Diagnostic Chemicals , Ltd., Aug 27, 1996 |