FDA Device Recall Z-0148-2015: Siemens Healthcare Diagnostics, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0148-2015.

Recall Res Number

Z-0148-2015

Recalling Firm / Manufacturer

Siemens Healthcare Diagnostics, Inc.

FEI Number

2517506

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2014-09-24

Date Posted

2014-10-29

Date Terminated

2016-08-17

Product Code

DIP

Event Number

69372

Product Quantity

1733

Product Description siemens Dimension Phenytoin Flex Reagent Cartridge The PTN method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.

Reason for Recall Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across the PTN assay range.

Action Details Siemens sent an Urgent Medical Device Recall Notification dated September 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed as follows: " Discontinue use and discard any remaining inventory of PTN lot FA5154, and complete the attached form indicating your replacement product needs in the attached Field Correction Effectiveness Form. " Siemens will replace any unused inventory of the affected lot at no charge. We apologize for the inconvenience this situation may have cause. If you have any questions, please contact Siemens Customer Care Center - Technical Solutions at (800) 441-9250, or your local Siemens technical support representative.

Distribution Pattern Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of Australia, Brazil, Bahamas, Canada, Chile, India, Japan and Uruguay

Code Information / Serial Numbers lot FA5154, exp. 2015-06-03

Related Establishments / Registrations

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ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319808 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319809 View Registration
BECKMAN COULTER, INC. Registration: 2050010 View Registration
BECKMAN COULTER, INC. Registration: 2050012 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 2250051 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
DENKA CO., LTD. Registration: 3003871639 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
Microgenics Corporation Registration: 3010939897 View Registration
Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610529 View Registration

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Medical Device Recall: Z-0148-2015

Recall Parameters & Description

Related Establishments / Registrations

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