FDA Device Recall Z-1127-2007: Instrumentation Laboratory Co.

Recall Res Number

Z-1127-2007

Recalling Firm / Manufacturer

Instrumentation Laboratory Co.

FEI Number

1217183

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2007-06-19

Date Posted

2007-08-07

Date Terminated

2012-05-23

Product Code

GKP

Event Number

38234

Product Quantity

94

Product Description Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000

Reason for Recall ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube.

Action Details Instrumentation Laboratory notiifed the distributor Beckman Coulter on 6/19/2007. Beckman Coulter notified their customers and provided a copy with the Instructions for Recovery Procedure on how to avoid contamination from probe leaks.

Distribution Pattern Nationwide.

Code Information / Serial Numbers Serial numbers prior to 07060782

Fisher Diagnostics Registration: 1181121 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 1217183 View Registration
HELENA LABORATORIES, CORP. Registration: 1644474 View Registration
DIAGNOSTICA STAGO, INC. Registration: 2245451 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SYSMEX CORPORATION KAKOGAWA FACTORY Registration: 3002759288 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
Sysmex America, Inc. Registration: 3009711478 View Registration
Sysmex RA Co., LTD, Main Office Registration: 3010188766 View Registration
BEMOTEC GMBH Registration: 3010362364 View Registration
SYSMEX CORPORATION Registration: 3010421384 View Registration
SYSMEX CORPORATION i-SQUARE Registration: 3010960914 View Registration
Sysmex America, Inc. - Vernon Hills Registration: 3020704087 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
Diagnostica Stago - Gennevilliers Registration: 8043723 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-1127-2007

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