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Terminated

Homogeneous 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.

FDA Recall Z-0921-2012 · Posted 2012-01-27

Recalling FirmCatch Incorporated
Recall StatusTerminated
Product CodeLPS
Date Initiated2011-06-27
Date Terminated2012-07-11
Product Quantity47 kits

Reason for Recall

Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method will not calibrate due to Reagent R1 had prematurely decayed.

Firm Action

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

Distribution Pattern

Product distributed in PA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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