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U.S. Department of Health and Human Services

Class 2 Device Recall Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method

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 Class 2 Device Recall Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Methodsee related information
Date Initiated by FirmJune 27, 2011
Date PostedJanuary 27, 2012
Recall Status1 Terminated 3 on July 11, 2012
Recall NumberZ-0921-2012
Recall Event ID 60811
Product Classification Urinary homocystine (nonquantitative) test system - Product Code LPS
ProductHomogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number E02-057-02. A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.
Code Information Lot D1101303
FEI Number 3005002431
Recalling Firm/
Manufacturer		 Catch Incorporated
11822 N Creek Pkwy N Ste 107
Bothell WA 98011-8203
For Additional Information ContactS.D. Lawson
425-402-8960
Manufacturer Reason
for Recall		Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method will not calibrate due to Reagent R1 had prematurely decayed.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionCatch Inc. sent an "URGENT-PRODUCT RECALL" letter dated 27 June 2011 to one sole customer. The letter described the product, problem, and actions to be taken by the customer. A reply form was attached to the letter for the customer to complete and return via fax at 425-402-8954. Please contact the firm at 425-402-8960 for questions regarding this recall.
Quantity in Commerce47 kits
DistributionProduct distributed in PA.
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.
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