FDA Device Recall Z-0915-05: Instrumentation Laboratory Co.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0915-05.

Recall Res Number

Z-0915-05

Recalling Firm / Manufacturer

Instrumentation Laboratory Co.

FEI Number

1217183

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2005-05-19

Date Posted

2005-06-21

Date Terminated

2006-12-06

Product Code

JPA

Event Number

32155

Product Quantity

617 units

Product Description ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent

Reason for Recall Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy

Action Details Instrumentation Laboratory issued an 'Urgent Product Notification' on 5/19/2005 to Beckman Coulter, Miami FL (DIstributor) to provide the written notification and advise customers to review PT curves an any patient on anticagulant treatment who reports a low result , and manually view the curve where a PT is flagged. A software upgrade will be availabel in July 2005.

Distribution Pattern Nationwide Canada

Code Information / Serial Numbers Models: 290001 999001 with SN''s beginning with 05041164 280000 with S/N''s beginning with 0505354

Related Establishments / Registrations

PENTAPHARM AG Registration: 1000340866 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 1217183 View Registration
HAEMONETICS CORPORATION Registration: 1219343 View Registration
HiArc Registration: 1219738 View Registration
BIONOSTICS, INC. Registration: 1220649 View Registration
HELENA LABORATORIES, CORP. Registration: 1618982 View Registration
HELENA LABORATORIES, CORP. Registration: 1644474 View Registration
MEDTRONIC PERFUSION SYSTEMS Registration: 1718389 View Registration
SIENCO, INC. Registration: 1719400 View Registration
INOVA DIAGNOSTICS, INC. Registration: 2026994 View Registration
R & D BATTERIES, INC. Registration: 2132111 View Registration
MEDTRONIC PERFUSION SYSTEMS Registration: 2184009 View Registration
DIAGNOSTICA STAGO, INC. Registration: 2245451 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 2431530 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
Accriva Diagnostics, Inc. Registration: 3002721930 View Registration
BIT Analytical Solutions GmbH Registration: 3003601075 View Registration
TCOAG DEUTSCHLAND GMBH Registration: 3003943960 View Registration
BERND RICHTER GMBH Registration: 3004035727 View Registration
Invetech Pty Ltd Registration: 3005269352 View Registration
TEM Innovations GmbH Registration: 3005792925 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
COAGUSENSE INC Registration: 3007507465 View Registration
SYSMEX CORPORATION SEISHIN FACTORY Registration: 3007701696 View Registration
Instrumentation Laboratory SpA Registration: 3007719797 View Registration
TCOAG IRELAND LIMITED Registration: 3008386529 View Registration
Sysmex America, Inc. Registration: 3009711478 View Registration
SYSMEX CORPORATION Registration: 3010421384 View Registration
Stellartech Research Corp. Registration: 3010653929 View Registration
SYSMEX CORPORATION i-SQUARE Registration: 3010960914 View Registration
INSTRUMENTATION LABORATORY SPA Registration: 3012348571 View Registration
PEROSPHERE TECHNOLOGIES INC. Registration: 3015222335 View Registration
Haemonetics Corporation Registration: 3019849102 View Registration
Sysmex America, Inc. - Vernon Hills Registration: 3020704087 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
LEICA BIOSYSTEMS MELBOURNE PTY LTD Registration: 8020030 View Registration
Diagnostica Stago - Gennevilliers Registration: 8043723 View Registration
BIOKIT S.A. Registration: 9610746 View Registration
Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration
SYSMEX CORPORATION TECHNO PARK Registration: 9613959 View Registration

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Medical Device Recall: Z-0915-05

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer