Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
FDA device recall Z-0015-2008 · posted 2007-10-04 · Terminated
Recall details
- Recalling firm
- Thermo Fisher Scientific
- Reason for recall
- Method is susceptible to positive interference from endogenous ALT in patient samples.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JIF
- Quantity affected
- 6,882 units
- Distribution
- Worldwide, including USA, Ecuador, and Canada.
- Date initiated
- 2007-07-24
- Date posted
- 2007-10-04
- Date terminated
- 2007-12-18
- Location
- Pittsburgh, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) (K974620) | Trace America, Inc. | 1998-01-02 |