Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number E02-057-02. A homocysteine test system
FDA device recall Z-0921-2012 · posted 2012-01-27 · Terminated
Recall details
- Recalling firm
- Catch Incorporated
- Reason for recall
- Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method will not calibrate due to Reagent R1 had prematurely decayed.
- Action taken
- Catch 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LPS
- Quantity affected
- 47 kits
- Distribution
- Product distributed in PA.
- Date initiated
- 2011-06-27
- Date posted
- 2012-01-27
- Date terminated
- 2012-07-11
- Location
- Bothell, WA
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