Recall Z-0448-2009 ยท LPS Urinary Homocystine (Nonquantitative) Test System
Catch Incorporated
Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2 brand names. The first brand name Catch, the label reads "CATCH Catch Inc., Bothell, WA 98011 HOMOCYSTEINE REAGENT KIT, Catalog Number A11167, 100 Test Kit, Manufactured at Intersect Systems, Inc., Longview, WA 98632". The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1 HCY A (2
| Date | Jan 6, 2009 (initiated Jan 18, 2007) |
| Status | Terminated |
| Reason | A high homocysteine level can be reported as falsely low. |
| Root cause | Device Design |
| Action | On 01/18/07 an "URGENT: PRODUCT CORRECTIVE ACTION" letter was sent to the consignees. The letter states the circumstances in which a high homocysteine rate can result in a false low homocysteine rate, a work around for the problem which a flag must be programmed into the user defined homocysteine test parameters and instructions to advise their customers about the situation was addressed in the letter so the consignees can take the recommended corrective action. A confirmation sheet was included with the letter to be signed by a representative of each distributor and returned to Catch Inc. |
| Quantity | 2,699 kits |
| Distribution | CA and PA. |
| FDA record | Open on fda.gov |