Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quant

FDA device recall Z-0541-2014 · posted 2013-12-19 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.

Action taken

Siemens sent a Urgent Medical Device Recall letter dated September 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Actions to be taken by Customer: Please discontinue use and discard any remaining inventory of Dimension Vista HCYS Flex reagent cartridge (Catalog# K7044) lot 13064MA. Please complete the attached form and fax it to (302) 631-8467 to facilitate your no charge replacement needs. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center- Technical Solutions or your local Siemens technical support representative. For further questions please call (800) 441-9250.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

LPS

Quantity affected

302

Distribution

Worldwide Distribution - US Distribution including the states of OH, MD, CO, NJ, IA, NC, VA, WI and DC., and the countries of Austria, Denmark, France, Italy, Netherlands and Norway.

Date initiated

2013-09-18

Date posted

2013-12-19

Date terminated

2014-10-01

Location

Newark, DE

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