Z-0015-2008

Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic

Name: Z-0015-2008 Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic
Creator: Thermo Fisher Scientific
Published: 2007-07-24
License: https://open.fda.gov/license/

Thermo Fisher Scientific Oy / initiated 2007-07-24 / Terminated / root cause: design

FDA source

Thermo Fisher Scientific began a recall of Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic on 2007-07-24. The reason FDA records is "Method is susceptible to positive interference from endogenous ALT in patient samples". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0015-2008
Status: Terminated
Initiated: 2007-07-24
Posted: 2007-10-04
Terminated: 2007-12-18
Recalling firm: Thermo Fisher Scientific Oy
Product: Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
Product code: JIF Enzymatic Method, Ammonia
Reason for recall: Method is susceptible to positive interference from endogenous ALT in patient samples.
Root cause tag: design
FDA 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 in commerce: 6,882 units
Distribution: Worldwide, including USA, Ecuador, and Canada.
Product codes and 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.

Product code JIF

K974620Class IAmmonia-Incorporating Dynamic Stabilization Technology (Dst)Trace America, Inc. / cleared 1998-01-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)