FDA Device Recall Z-0895-2018: Instrumentation Laboratory Co.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0895-2018.

Recall Res Number

Z-0895-2018

Recalling Firm / Manufacturer

Instrumentation Laboratory Co.

FEI Number

1217183

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2017-08-02

Date Posted

2018-03-03

Date Terminated

2019-03-29

Product Code

GJS

Event Number

79165

Product Quantity

14,894 kits

Product Description Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

Reason for Recall Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.

Action Details On August 2, 2017, Instrumentation Laboratory sent an Urgent Medical Device Removal letters dated August 2, 2017 to their customers. On October 5, 2017 Instrumentation Laboratory expanded their recall adding 3 additional lots to a second Urgent Medical Device Removal letter. On February 26, 2018, Instrumentation Laboratory expanded their recall a 3rd time to include 1 additional lot to a third Urgent Medical Device Removal letter. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete a Mandatory Tracking Response form. For questions contact your Customer Service Representative at 1-800-955-9525, option #1.

Distribution Pattern Worldwide Distribution - US Nationwide

Code Information / Serial Numbers Lots: N1166235, N0177760, N0278358, N0478057, N0479504 & N0278177.

Related Establishments / Registrations

Fisher Diagnostics Registration: 1181121 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 1217183 View Registration
NOVA BIOMEDICAL CORPORATION Registration: 1219029 View Registration
HELENA LABORATORIES, CORP. Registration: 1618982 View Registration
ARKRAY FACTORY USA, INC. Registration: 1832816 View Registration
R2 DIAGNOSTICS, INC. Registration: 1835316 View Registration
CLINIQA CORPORATION Registration: 2085064 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
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
Accriva Diagnostics, Inc. Registration: 3002721930 View Registration
BIOMEDICA DIAGNOSTICS INC. Registration: 3003691680 View Registration
ABBOTT POINT OF CARE CANADA LIMITED Registration: 3005643513 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
COAGUSENSE INC Registration: 3007507465 View Registration
TCOAG IRELAND LIMITED Registration: 3008386529 View Registration
ILINE MICROSYSTEMS S.L. Registration: 3010285483 View Registration
DYLAN LUCAS INTERNATIONAL INC Registration: 3011689956 View Registration
QUIPMENT INC. Registration: 3012302888 View Registration
ORTA MEDICAL LTD Registration: 3013188547 View Registration
VEENAK INTERNATIONAL LIMITED Registration: 3013298431 View Registration
High Technology, Inc. Registration: 3013660430 View Registration
IKOR SISTEMAS ELECTRONICOS, SL Registration: 3015499222 View Registration
KEYPAR LIMITED Registration: 3025915415 View Registration
I-SENS Songdo Factory 2 Registration: 3030186688 View Registration
SUPPLY MAX NY INC Registration: 3033967997 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration
Diagnostica Stago - Taverny Registration: 9710666 View Registration

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Medical Device Recall: Z-0895-2018

Recall Parameters & Description

Related Establishments / Registrations

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