FDA Medical Device Recalls (openFDA)
Thermo Fisher Scientific: Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
- Recall number
- Z-0015-2008
- Recalling firm
- Thermo Fisher Scientific
- Product
- Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
- Status
- Terminated
- Initiated
- 2007-07-24
- Posted
- 2007-10-04
- Terminated
- 2007-12-18
- Reason
- Method is susceptible to positive interference from endogenous ALT in patient samples.
- 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
- 6,882 units
- Distribution
- Worldwide, including USA, Ecuador, and Canada.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K974620"]
- PMA numbers
- not on file
- Product code
- JIF
- Firm FEI
- 2550000
- Firm city
- Pittsburgh
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28