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U.S. Department of Health and Human Services

Class 2 Device Recall HemosIL RecombiPlasTin

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  Class 2 Device Recall HemosIL 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-1246-06
Recall Event ID 35632
510(K)Number K043184  
Product Classification Test, Time, Prothrombin - Product Code GJS
Product HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit consists of: RecombiPlasTin (RTF): 5 x 8 mL or 20 mL vials of lyophilized recombinant human tissue factor, synthetic phospholipids with stabilizers, preservative and buffer; and RecombiPlasTin Diluent (RTF Diluent): 5 x 8 or 20 mL vials of an aqueous solution of calcium chloride, polybrene and a preservative. ---
FOR IN VITRO DIAGNOSTIC USE.
Code Information Product No.0020002900 (8mL): Lots N0649021, N0253072, N0253739, N1150411; Part No. 0020003000 (20 mL): Lots N0347531, N0447950, N0740293, N1040969, N1141498, N0152736, N0453415, N0454252, N0756711, N0958473, N1150445, N1250485, N1250619, N0160792.
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 2		 Other
Action "Urgent Product Notifications" were sent to IL customers on 3/07/06 through its distributor, Beckman Coulter.
Quantity in Commerce 8 mL: 10,473; 20 mL: 5110 (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 = INSTRUMENTATION LABORATORY CO.
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