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U.S. Department of Health and Human Services

Class 3 Device Recall Ammonia Liquid Stable Reagent

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 Class 3 Device Recall Ammonia Liquid Stable Reagentsee related information
Date Initiated by FirmJuly 24, 2007
Date PostedOctober 04, 2007
Recall Status1 Terminated 3 on December 18, 2007
Recall NumberZ-0015-2008
Recall Event ID 39389
510(K)NumberK974620 
Product Classification in vitro diagnostic - Product Code JIF
ProductAmmonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
Code Information 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.
FEI Number 2550000
Recalling Firm/
Manufacturer		 Thermo Fisher Scientific
171 Industry Dr
Pittsburgh PA 15275-1015
For Additional Information ContactBola Nicholson
412-747-4039
Manufacturer Reason
for Recall		Method is susceptible to positive interference from endogenous ALT in patient samples.
FDA Determined
Cause 2		Device Design
ActionThe 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 Commerce6,882 units
DistributionWorldwide, including USA, Ecuador, and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JIF
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