Class 2 Device Recall Hemoliance RecombiPlasTin

• Date Initiated by Firm: March 07, 2006
• Date Posted: July 18, 2006
• Recall Status: Terminated on August 11, 2006
• Recall Number: Z-1247-06
• Recall Event ID: 35632
• 510(K)Number: K925604
• Product Classification: Test, Time, Prothrombin - Product Code GJS
• Product: Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of Hemoliance RecombiPlasTin Diluent. Hemoliance RecombiPlasTin after reconstitution with Hemoliance RecombiPlasTin Diluent is a liposomal preparation of recombinant human tissue factor and purified phospholipids, calcium chloride, buffer and a preservative. The use of recombinant human tissue factor and purified phospholipids assures uniformity in reagent purity, ISI values and performance from lot to lot. Once reconstituted, it is ready for use in the one-stage PT test. Hemoliance RecombiPlasTin Diluent is an aqueous solution of calcium chloride and a preservative. --- FOR IN VITRO DIAGNOSTIC USE.
• Code Information: Product No.49732750 (5 mL): Lots N0448239, N0549190, N0940581, N0353406, N0857200, N1050152; Product No. 49732720 (20 mL): Lots N0347895, N0548959, N0749495, N0940543, N0940586, N1242409, N0353410, N0454257, N0857199, N1050143.
• Recalling Firm/ Manufacturer: Instrumentation Laboratory Co.; 113 Hartwell Ave; Lexington MA 02421-3125
• For Additional Information Contact: Ms. Carol Marble; 781-861-4467
• Manufacturer Reason for Recall: Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection).
• FDA Determined Cause: Other
• Action: "Urgent Product Notifications" were sent to IL customers on 3/07/06 through its distributor, Beckman Coulter.
• Quantity in Commerce: 5 mL: 3870; 20 mL: 29,007 (all Domestic)
• Distribution: Nationwide
• 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 = GJS