Recall Z-0793-2013 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
Hitachi Chemical Diagnostics Inc
OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
| Date | Feb 7, 2013 (initiated Dec 21, 2012) |
| Status | Terminated |
| Reason | There is no evidence that a visual inspection was performed on one tray of coverslips. Possibility of a low fill volume which could lead to a false negative results. |
| Root cause | Process control |
| Action | Hitachi sent an Urgent Product Recall Notification letter dated December 21, 2012, to the affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was instructed to discontinue distribution and destroy any remaining inventory of the affected product at their location per their local waste ordinances, determine if any of their customers are using or have inventory of the affected product, rquest that their customers review all patient results reported with the use of the affectted product. The customer was instructed to tell |
| Quantity | 20 kits |
| Distribution | Worldwide Distribution - France only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051677 | OPTIGEN ALLERGEN SPECIFIC IGE ASSAY Hitachi Chemical Diagnostics, Inc., Jan 23, 2006 |