Thermo Fisher Scientific Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
Brand
Thermo Fisher Scientific
Lot Codes / Batch Numbers
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.
Products Sold
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.
Thermo Fisher Scientific is recalling Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic. due to Method is susceptible to positive interference from endogenous ALT in patient samples.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Method is susceptible to positive interference from endogenous ALT in patient samples.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026