FDA Device Recall Z-0039-2017: Siemens Healthcare Diagnostics, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0039-2017.

Recall Res Number

Z-0039-2017

Recalling Firm / Manufacturer

Siemens Healthcare Diagnostics, Inc.

FEI Number

2517506

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2016-08-03

Date Posted

2016-10-04

Date Terminated

2017-05-11

Product Code

CIC

Event Number

74987

Product Quantity

5,991 cartridges

Product Description Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB

Reason for Recall Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.

Action Details Siemens mailed on August 09, 2016, an Urgent Medical Device Recall letter to all customers who purchased the CA lot 16060BB. The notification letter requested that customers discontinue use and discard the affected kit.

Distribution Pattern Distributed Nationwide and the countries of : Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Germany, Italy, Japan, Netherlands, Portugal, Saudi Arabia, South Korea, Slovenia, and Spain.

Code Information / Serial Numbers Device Listing No: D011443 Batch Number 16060BB

Related Establishments / Registrations

HEMAGEN DIAGNOSTICS, INC. Registration: 1181055 View Registration
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STANBIO LABORATORY Registration: 1616487 View Registration
HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
TECO DIAGNOSTICS Registration: 1832216 View Registration
CLINIQA CORPORATION Registration: 2085064 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
HORIBA ABX SAS Registration: 3000148879 View Registration
Infrared Laboratory Systems dba SYNERMED Registration: 3003593973 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
INPECO SA Registration: 3010825766 View Registration
High Technology, Inc. Registration: 3013660430 View Registration
BIALEX LAB Registration: 3021841051 View Registration
WIENER LABORATORIOS S.A.I.C. Registration: 8040374 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610529 View Registration

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Medical Device Recall: Z-0039-2017

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer