Recall Z-0015-2008
Thermo Fisher Scientific · initiated July 24, 2007
Product
Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
Codes / lots: Lot numbers FL029 exp 8/30/07, GB059 exp 11/30/07, GD005 exp 12/30/07, GE093 exp 1/30/08, GH034 exp 4/30/08, GJ039 exp 7/30/08, HB064 exp 11/30/08, and HD035 exp 1/30/09.
Reason for recall
Method is susceptible to positive interference from endogenous ALT in patient samples.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-0015-2008
- Initiated
- July 24, 2007
- Posted by FDA
- October 4, 2007
- Terminated
- December 18, 2007
- Product code
- JIF – Enzymatic Method, Ammonia
- Quantity
- 6,882 units
- Distribution
- Worldwide, including USA, Ecuador, and Canada.
- Recalling firm
- Thermo Fisher Scientific, Pittsburgh, PA