FDA Device Recall Z-0039-2008: Diagnostica Stago, Inc.

Recall Res Number

Z-0039-2008

Recalling Firm / Manufacturer

Diagnostica Stago, Inc.

FEI Number

2245451

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2007-07-30

Date Posted

2007-10-11

Date Terminated

2007-12-17

Product Code

GKP

Event Number

39419

Product Quantity

41 units installed

Product Description STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.

Reason for Recall Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.

Action Details Recall notification letters were mailed to consignees on 7/30/07 by first class mail.

Distribution Pattern Nationwide.

Code Information / Serial Numbers BT7 7016065; BT7 7016067; BT7 7016068; BT7 7016072; BT7 7016074; BT7 7016075; BT8 7016076; BT7 7016078; BT7 7017080; BT7 7016090; BT7 7016091; BT8 7026119; BT8 7026126; BT8 7026127; BT8 7026128; BT8 7026130; BT7 7026134; BT7 7026135; BT7 7026140; BT8 7026146; BT8 7026147; BT8 7026148; BT8 7026149; BT8 7026150; BT7 7026151; BT7 7026152; BT7 7026153; BT7 7026154; BT7 7026155; BT7 7026156; BT7 7026157; BT7 7036164; BT7 7036166; BT7 7036167; BT7 7036168; BT7 7036177; BT7 7036192.

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-0039-2008

Recall Parameters & Description

Related Establishments / Registrations

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