Recall Z-0921-2012 ยท LPS Urinary Homocystine (Nonquantitative) Test System
Catch Incorporated
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.
| Date | Jan 27, 2012 (initiated Jun 27, 2011) |
| Status | Terminated |
| Reason | Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method will not calibrate due to Reagent R1 had prematurely decayed. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 47 kits |
| Distribution | Product distributed in PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.