FDA Device Recall Z-0127-2015: Siemens Healthcare Diagnostics, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0127-2015.

Recall Res Number

Z-0127-2015

Recalling Firm / Manufacturer

Siemens Healthcare Diagnostics, Inc.

FEI Number

2517506

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2014-08-14

Date Posted

2014-10-24

Date Terminated

2015-08-10

Product Code

LCP

Event Number

69334

Product Quantity

20043

Product Description Dimension Vista HbA1c

Reason for Recall In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% t

Action Details An Urgent Medical Device Correction, dated August 2014, was provided to all Dimension Vista HbA1c customers who received the affected lots to notify them of the issue, the potential risk to health, and actions to be taken by customers.

Distribution Pattern Worldwide Distribution: US (nationwide) and country of: Canada.

Code Information / Serial Numbers catalog #K3105A, material #10470481, All in-date lots

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Medical Device Recall: Z-0127-2015

Recall Parameters & Description

Related Establishments / Registrations

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