FDA Device recall Z-0832-2015

HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company

FDA Device
Class II
terminated
Published 2014-12-31

On 2014-12-31 the FDA classified a Class II recall of HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company by Instrumentation Laboratory, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0832-2015
Classification	Class II
Status	terminated
Initiated	2014-11-21
Published	2014-12-31
Last updated	2026-09-13 11:53 UTC
Company	Instrumentation Laboratory
Distribution	US

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.

Identifiers

code_info	Lots: N1122175, exp. date 11/30/2014; N0132936, exp. date 1/31/2015; N0233302, exp. date 2/28/2015; N0333382, exp.… Lots: N1122175, exp. date 11/30/2014; N0132936, exp. date 1/31/2015; N0233302, exp. date 2/28/2015; N0333382, exp. date 3/31/2015; E0333382, exp. date 3/31/2015; N0333626, exp. date 3/31/2015; N0433932, exp. date 4/30/2015; N0634953, exp. date 6/30/2015; N0735317, exp. date 5/31/2015; N0735599, exp. date 7/31/ 2015; N0836106, exp. date 8/31/2015; N0936197, exp. date 9/30/2015; N0349325, exp. date 12/31/2015; N1222324, exp. date 12/31/2015; N0148094, exp. date 12/31/2015; N0248652, exp. date 2/29/2016; N0249017, exp. date 2/29/2016; N0449790, exp. date 4/30/2016; N0440009, exp. date 4/30/2016.

code_info

Lots: N1122175, exp. date 11/30/2014; N0132936, exp. date 1/31/2015; N0233302, exp. date 2/28/2015; N0333382, exp.…

Lots: N1122175, exp. date 11/30/2014; N0132936, exp. date 1/31/2015; N0233302, exp. date 2/28/2015; N0333382, exp. date 3/31/2015; E0333382, exp. date 3/31/2015; N0333626, exp. date 3/31/2015; N0433932, exp. date 4/30/2015; N0634953, exp. date 6/30/2015; N0735317, exp. date 5/31/2015; N0735599, exp. date 7/31/ 2015; N0836106, exp. date 8/31/2015; N0936197, exp. date 9/30/2015; N0349325, exp. date 12/31/2015; N1222324, exp. date 12/31/2015; N0148094, exp. date 12/31/2015; N0248652, exp. date 2/29/2016; N0249017, exp. date 2/29/2016; N0449790, exp. date 4/30/2016; N0440009, exp. date 4/30/2016.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0832-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.