FDA Device Recall Z-0015-2008: Thermo Fisher Scientific

Recall Res Number

Z-0015-2008

Recalling Firm / Manufacturer

Thermo Fisher Scientific

FEI Number

2550000

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2007-07-24

Date Posted

2007-10-04

Date Terminated

2007-12-18

Product Code

JIF

Event Number

39389

Product Quantity

6,882 units

Product Description Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.

Reason for Recall Method is susceptible to positive interference from endogenous ALT in patient samples.

Action Details The firm has updated the Limitations section of the Ammonia Reagent Package Insert and circulated a Technical Bulletin dated July 24, 2007 to all customers that have purchased Ammonia Reagent that is still within expiration date. A Notification of Change has been introduced and shall be placed within subsequent Ammonia Reagent Kits with a copy of the updated package insert; the notification of change informs customers that a change has been made to the package insert. Notifications of Change are placed within kits for 6 months from the date of issue.

Distribution Pattern Worldwide, including USA, Ecuador, and Canada.

Code Information / Serial Numbers Lot numbers FL029 exp 8/30/07, GB059 exp 11/30/07, GD005 exp 12/30/07, GE093 exp 1/30/08, GH034 exp 4/30/08, GJ039 exp 7/30/08, HB064 exp 11/30/08, and HD035 exp 1/30/09.

Fisher Diagnostics Registration: 1181121 View Registration
HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
BECKMAN COULTER, INC. Registration: 2050010 View Registration
BECKMAN COULTER, INC. Registration: 2050012 View Registration
CLINIQA CORPORATION Registration: 2085064 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
INPECO SA Registration: 3010825766 View Registration
High Technology, Inc. Registration: 3013660430 View Registration
Sekisui Diagnostics P.E.I. Inc. Registration: 8020316 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610529 View Registration
SENTINEL CH. SPA Registration: 9681753 View Registration

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Medical Device Recall: Z-0015-2008

Recall Parameters & Description

Related Establishments / Registrations

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