Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
FDA Recall Z-0015-2008 · Posted 2007-10-04
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Recalling FirmThermo Fisher Scientific
Recall StatusTerminated
Product CodeJIF
Date Initiated2007-07-24
Date Terminated2007-12-18
Product Quantity6,882 units
Reason for Recall
Method is susceptible to positive interference from endogenous ALT in patient samples.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide, including USA, Ecuador, and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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