Instrumentation Laboratory Co. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Instrumentation Laboratory Co.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Instrumentation Laboratory Co. is recalling HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit consists of: RecombiPlasTin due to Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CU. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
"Urgent Product Notifications" were sent to IL customers on 3/07/06 through its distributor, Beckman Coulter.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026