FDA Device Recall Z-0778-2007: Instrumentation Laboratory Co.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0778-2007.

Recall Res Number

Z-0778-2007

Recalling Firm / Manufacturer

Instrumentation Laboratory Co.

FEI Number

1217183

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2007-03-27

Date Posted

2007-05-03

Date Terminated

2012-05-23

Product Code

CHL

Event Number

37719

Product Quantity

210

Product Description GEM Premier 4000 Laboratory Analyzer

Reason for Recall Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result

Action Details Instrumentation Labs on 3/2707 notified Service Reps to perform on site mandatory upgrade. The foreign counterparts were advised by email on 3/21/07

Distribution Pattern Worldwide, including USA, Australia, Austria, Greece, Spain, Netherlands, Great Britain, France, Germany, Italy, and Sweden

Code Information / Serial Numbers Serial numbers prior to 07020343 with Software versions prior to V1.1.3

Related Establishments / Registrations

BIOTECNICA INSTRUMENTS, Srl Registration: 1000455123 View Registration
SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
Fisher Diagnostics Registration: 1181121 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 1217183 View Registration
NOVA BIOMEDICAL CORPORATION Registration: 1219029 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
BIONOSTICS, INC. Registration: 1220649 View Registration
MEDICA CORP. Registration: 1220972 View Registration
PHOENIX DIAGNOSTICS, INC. Registration: 1222035 View Registration
ELITechGroup Inc Registration: 1717966 View Registration
BECKMAN COULTER, INC. Registration: 2050012 View Registration
ABBOTT POINT OF CARE INC. Registration: 2245578 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 2431530 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
Siemens Healthcare Diagnostics Inc Registration: 3002637618 View Registration
RADIOMETER MEDICAL APS Registration: 3002807968 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
EDAN INSTRUMENTS, INC. Registration: 3003971136 View Registration
OPTI MEDICAL SYSTEMS INC. Registration: 3004102403 View Registration
EPOCAL, INC. Registration: 3004959793 View Registration
ABBOTT POINT OF CARE CANADA LIMITED Registration: 3005643513 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
Radiometer Sp. z o.o Registration: 3007490412 View Registration
VitalScientific Registration: 3007662974 View Registration
Katmai Health Services LLC Registration: 3012104670 View Registration
Epocal Inc Registration: 3012817228 View Registration
Radiometer Solutions Sp. z o.o. Registration: 3013513377 View Registration
Radiometer Minneapolis Registration: 3014506106 View Registration
KATMAI INTEGRATED SOLUTIONS Registration: 3015997711 View Registration
Nova Biomedical Corporation Registration: 3023162659 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
VitalScientific B.V. Registration: 8030478 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD Registration: 9610633 View Registration

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Medical Device Recall: Z-0778-2007

Recall Parameters & Description

Related Establishments / Registrations

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