Reported Dec 31, 2014 · Terminated
HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent…
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 PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
- Lot codes and dates
19 of 19 products
Products covered by this recall # Product as published 1 N1122175, exp. date 11/30/2014 2 N0132936, exp. date 1/31/2015 3 N0233302, exp. date 2/28/2015 4 N0333382, exp. date 3/31/2015 5 E0333382, exp. date 3/31/2015 6 N0333626, exp. date 3/31/2015 7 N0433932, exp. date 4/30/2015 8 N0634953, exp. date 6/30/2015 9 N0735317, exp. date 5/31/2015 10 N0735599, exp. date 7/31/ 2015 11 N0836106, exp. date 8/31/2015 12 N0936197, exp. date 9/30/2015 13 N0349325, exp. date 12/31/2015 14 N1222324, exp. date 12/31/2015 15 N0148094, exp. date 12/31/2015 16 N0248652, exp. date 2/29/2016 17 N0249017, exp. date 2/29/2016 18 N0449790, exp. date 4/30/2016 19 N0440009, exp. date 4/30/2016. - Amount recalled
- USA: 4088 kits; Foreign: 97,925 kits
Where it was sold
Why it was recalled
Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of the typical white to off-white color. Vials exhibiting this yellow/brownish color were observed to cause prolonged prothrombin (PT) clotting times.
This product could cause temporary or reversible health problems — stop using it.
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