Class 2 Device Recall Test Kit

• Date Initiated by Firm: January 18, 2007
• Date Posted: January 06, 2009
• Recall Status: Terminated on September 28, 2010
• Recall Number: Z-0448-2009
• Recall Event ID: 48734
• 510(K)Number: K011689 K011692
• Product Classification: Reagent Test Kit - Product Code LPS
• Product: 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 (28mL), Homocysteine Reagent R2 HCY R2 (13.5 mL), Homocysteine HCY C (2.8 mL), Homocysteine 0.0 umol/L (2mL) and Homocysteine 27.0 umol/L (2mL). The second brand name Equal the label reads "EQual DIAGNOSTICS FOR IN VITRO DIAGNOSTIC USE ONLY HOMOCYSTEINE 3-Part Kit w/calibrators, Catalog Number E02-058-03, Equal Diagnostic, Exton, PA 19341". The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1, Homocysteine Reagent R2, Homocysteine Reagent R3, Homocysteine Calibrator 0.0 umol/L and Homocysteine Calibrator 27.0 umol/L. All individual kits are packaged into individual boxes and then packaged into 1 box. Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in serum and plasma.
• Code Information: Catch Inc. - Lot Numbers and expiration dates include L05037 2007-05, B06003 2007-08, F06011 2007-12 and H06021 200802. Equal Diagnostics -Lot Number and expiration date include F06011 2007-12. First digit is the month of manufacture, A = Jan, B = Feb, but I is not used. Second and third digits are the year of manufacture, 05 = 2005. The remaining digits are sequential numbers for the next lot.
• Recalling Firm/ Manufacturer: Catch Incorporated; 11822 N Creek Pkwy N Ste 107; Bothell WA 98011-8203
• For Additional Information Contact: 425-402-8960
• Manufacturer Reason for Recall: A high homocysteine level can be reported as falsely low.
• FDA Determined 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. Contact Catch Inc. at 1.425.402.8960 for assistance.
• Quantity in Commerce: 2,699 kits
• Distribution: CA and PA.
• Total Product Life Cycle: TPLC 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.

• 510(K) Database: 510(K)s with Product Code = LPS; 510(K)s with Product Code = LPS