FDA Device Recall Z-0516-2014: Instrumentation Laboratory Co.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0516-2014.

Recall Res Number

Z-0516-2014

Recalling Firm / Manufacturer

Instrumentation Laboratory Co.

FEI Number

1217183

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2013-11-15

Date Posted

2013-12-16

Date Terminated

2014-03-25

Product Code

GGN

Event Number

66894

Product Quantity

84561 kits

Product Description HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

Reason for Recall HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

Action Details Instrumentation Laboratory issued Important Correction Notice via USPS to US customers dated November 2013 advising users in the US that unassayed controls are not acceptable for use in their unassayed (non-value assigned) format. IL will no longer sell or distribute controls without assayed values for the US market as of November 15, 2013, and are converting US customers to an assayed control format. Additional contact with customers via phone calls and a reminder email. An enclosed response tracking form provided to be returned. For technical questions, contact the IL Technical Support Center at 1-800-678-0710, Option # 6 (ACL Coagulation Products). For replacement product if value assignments are not available for your product lot, please contact your IL Customer Service Representative at 1-800-955-9525, Option # 6. For questions regarding this recall call 781-861-4467.

Distribution Pattern Nationwide Distribution

Code Information / Serial Numbers All lots

Related Establishments / Registrations

PENTAPHARM AG Registration: 1000340866 View Registration
Fisher Diagnostics Registration: 1181121 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
MEDTRONIC PERFUSION SYSTEMS Registration: 1718389 View Registration
TECO DIAGNOSTICS Registration: 1832216 View Registration
GEORGE KING BIO-MEDICAL, INC. Registration: 1928890 View Registration
Bio-Rad Laboratories Inc. Registration: 2016706 View Registration
KAMIYA BIOMEDICAL COMPANY LLC Registration: 2084025 View Registration
CLINIQA CORPORATION Registration: 2085064 View Registration
MEDTRONIC PERFUSION SYSTEMS Registration: 2184009 View Registration
DIAGNOSTICA STAGO, INC. Registration: 2245451 View Registration
ABBOTT POINT OF CARE INC. Registration: 2245578 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 2431530 View Registration
Accriva Diagnostics, Inc. Registration: 3002721930 View Registration
TECHNOCLONE Registration: 3003453957 View Registration
BIOMEDICA DIAGNOSTICS INC. Registration: 3003691680 View Registration
SHIMA LABORATORIES CO., LTD. Registration: 3003985394 View Registration
HYPHEN BIOMED SASU Registration: 3004434070 View Registration
HART BIOLOGICALS LTD Registration: 3005261789 View Registration
Invetech Pty Ltd Registration: 3005269352 View Registration
ABBOTT POINT OF CARE CANADA LIMITED Registration: 3005643513 View Registration
TEM Innovations GmbH Registration: 3005792925 View Registration
TCOAG IRELAND LIMITED Registration: 3008386529 View Registration
Bio-Rad Laboratories Inc. Registration: 3010127294 View Registration
AALTO SCIENTIFIC LTD. Registration: 3011325031 View Registration
5-DIAGNOSTICS Registration: 3012289015 View Registration
INSTRUMENTATION LABORATORY SPA Registration: 3012348571 View Registration
STS CORPORATION Registration: 3014150341 View Registration
Haemonetics Corporation Registration: 3019849102 View Registration
INFITEK CO., LTD. Registration: 3027645317 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
SCITEK GLOBAL CO.,LTD Registration: 3043088937 View Registration
LABPEAK CO.,LTD Registration: 3043138885 View Registration
Precision BioLogic Inc. Registration: 8043599 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
BIOKIT S.A. Registration: 9610746 View Registration
Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration
EUROTROL B.V. Registration: 9681518 View Registration
Diagnostica Stago - Taverny Registration: 9710666 View Registration

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Medical Device Recall: Z-0516-2014

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer