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U.S. Department of Health and Human Services

Class 2 Device Recall Hemoliance RecombiPlasTin

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  Class 2 Device Recall Hemoliance RecombiPlasTin see related information
Date Initiated by Firm March 07, 2006
Date Posted July 18, 2006
Recall Status1 Terminated 3 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/
Instrumentation Laboratory Co.
113 Hartwell Ave
Lexington MA 02421-3125
For Additional Information Contact Ms. Carol Marble
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 2
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 and Original Applicant = ORTHO DIAGNOSTIC SYSTEMS, INC.