Reported Jul 31, 2013 · Terminated
HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic…
Instrumentation Laboratory Co.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Instrumentation Laboratory Co. · 180 Hartwell Road · Bedford, MA · 01730-2443
Is this the product you have?
- 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.
- Lot codes and dates
14 of 14 products
Products covered by this recall # Product as published 1 N0716706 Exp. Date 5/31/2013 2 N0817321 Exp. Date 5/31/2013 3 E0917396 Exp. Date 9/30/2013, 4)) N0917378 Exp. Date 9/30/2013 4 N1118029 Exp. Date 10/31/2013 5 N0128669 Exp. Date 1/31/2014 6 N0329291 Exp. Date 2/28/2014 7 N0429596 Exp. Date 3/31/2014 8 N0520056 Exp. Date 5/31/2014 9 E0720822 Exp. Date 7/31/2014 10 N0821174 Exp. Date 8/31/2014 11 N091388 Exp. Date 9/30/2014 12 N0921522 Exp. Date 9/30/2014 13 N0132676 Exp. Date 1/31/2015 and 14 N1222567 Exp. Date 1/31/2015. - Amount recalled
- 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
Where it was sold
Why it was recalled
Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification.
This product could cause temporary or reversible health problems — stop using it.
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