Recall Z-0015-2008 ยท JIF Enzymatic Method, Ammonia
Thermo Fisher Scientific
Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
| Date | Oct 4, 2007 (initiated Jul 24, 2007) |
| Status | Terminated |
| Reason | Method is susceptible to positive interference from endogenous ALT in patient samples. |
| Root cause | Device Design |
| Action | The firm has updated the Limitations section of the Ammonia Reagent Package Insert and circulated a Technical Bulletin dated July 24, 2007 to all customers that have purchased Ammonia Reagent that is still within expiration date. A Notification of Change has been introduced and shall be placed within subsequent Ammonia Reagent Kits with a copy of the updated package insert; the notification of change informs customers that a change has been made to the package insert. Notifications of Change are placed within kits for 6 months from the date of issue. |
| Quantity | 6,882 units |
| Distribution | Worldwide, including USA, Ecuador, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974620 | AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) Trace America, Inc., Jan 2, 1998 |