FDA-Device2013-07-31Class II

HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.

Instrumentation Laboratory Co.
Hazard

Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification.

Sold states
Worldwide Distribution- US (nationwide) including states of: MA, ME, CT, NJ, NY, PA, MD, VA, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, MT, IL, MO, KS, NE, LA, AR, OK, TX, CO, ID, AZ, CA, OR, WA, AK, RI, VT and the countries of: Angola, Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Bulgaria, Canada, Caribbean, Chile, Colombia, Costa Rica, Czech, Denmark, Dubai, Ecuador, Egypt, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hungary, India, Indonesia, Iran, Israel, Italy, Jamaica, Jordan, Korea, Kosovo, Kuwait, Lebanon, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, Turkey, Ukraine, Uruguay, Vietnam, and Japan.
Affected count
Kits per product:1)11080, 2)11603, 3)11487, 4)11483, 5)11290, 6)11562, 7)11535, 8)11577, 9)11505, 10)11708,11)11579,12)11580, 13&14) not distributed
Manufactured in
180 Hartwell Road, N/A, Bedford, MA, United States
Products
HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1784-2013

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