Recall Z-0832-2015— Instrumentation Laboratory Co.

Name: FDA recall Z-0832-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-21

Class II · Terminated

Class II FDA medical device recall by Instrumentation Laboratory Co., initiated 2014-11-21, terminated 2016-01-26. It names one FDA 510(k) clearance: K060931. Product: 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).. Reason: 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..

Recalling firm: Instrumentation Laboratory Co.
Classification: Class II
Status: Terminated
Initiated: 2014-11-21
Terminated: 2016-01-26
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K060931 — HEMOSIL PT-FIBRINOGEN HS PLUSInstrumentation Laboratory CO·cleared 2006-05-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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).

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.