FDA Device Recall Z-1247-06: Instrumentation Laboratory Co.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-1247-06.

Recall Res Number

Z-1247-06

Recalling Firm / Manufacturer

Instrumentation Laboratory Co.

FEI Number

1217183

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-03-07

Date Posted

2006-07-18

Date Terminated

2006-08-11

Product Code

GJS

Event Number

35632

Product Quantity

5 mL: 3870; 20 mL: 29,007 (all Domestic)

Product Description Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of Hemoliance RecombiPlasTin Diluent. Hemoliance RecombiPlasTin after reconstitution with Hemoliance RecombiPlasTin Diluent is a liposomal preparation of recombinant human tissue factor and purified phospholipids, calcium chloride, buffer and a preservative. The use of recombinant human tissue factor and purified phospholipids assures uniformity in reagent purity, ISI values and performance from lot to lot. Once reconstituted, it is ready for use in the one-stage PT test. Hemoliance RecombiPlasTin Diluent is an aqueous solution of calcium chloride and a preservative. --- FOR IN VITRO DIAGNOSTIC USE.

Reason for Recall Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection).

Action Details "Urgent Product Notifications" were sent to IL customers on 3/07/06 through its distributor, Beckman Coulter.

Distribution Pattern Nationwide

Code Information / Serial Numbers Product No.49732750 (5 mL): Lots N0448239, N0549190, N0940581, N0353406, N0857200, N1050152; Product No. 49732720 (20 mL): Lots N0347895, N0548959, N0749495, N0940543, N0940586, N1242409, N0353410, N0454257, N0857199, N1050143.

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-1247-06

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer