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.
This recall has been terminated (originally issued July 18, 2006).
- Company
- Instrumentation Laboratory Co.
- Recall Initiated
- March 7, 2006
- Posted
- July 18, 2006
- Terminated
- August 11, 2006
- Recall Number
- Z-1246-06
- Quantity
- 8 mL: 10,473; 20 mL: 5110 (all Domestic)
- Firm Location
- Lexington, MA
- Official Source
- View on FDA website ↗
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).
Distribution
Nationwide
Lot / Code Info
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.
Root Cause
Other
Action Taken
"Urgent Product Notifications" were sent to IL customers on 3/07/06 through its distributor, Beckman Coulter.
More recalls by Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer.
P/N 2800...
Aug 7, 2007
GEM Premier 4000 Laboratory Analyzer
May 3, 2007
Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of H...
Jul 18, 2006
GEM PREMIER 3000
Jan 11, 2006