| Class 2 Device Recall HemosIL RecombiPlasTin | |
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
|
|
|
|