Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitati

FDA device recall Z-0253-2013 · posted 2012-11-06 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.

Action taken

Siemens sent a Urgent Field Safety Notice letter dated July 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. At this time Siemens Healthcare Diagnostics is conducting a voluntary recall for Dimension Vista HCYS Flex reagent cartridge lots 12062MA and 12066MA. Please immediately discontinue use and discard any remaining inventory of Dimension Vista HCYS (K7044) lots 12062MA and 12066MA. Please complete the attached form and fax it to (302)631-8467 to indicate that you have received this information. We ask that you forward this notification to anyone to whom you may have distributed this lot. Contact your Siemens Customer Service Center to report your no-charge replacement needs at 888-588-3916. If you have technical questions or concerns, please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance. We apologize for the inconvenience that this situation has caused. Thank you for your patience and continued support.

Root cause

Packaging

Status

Terminated

Product code

LPS

Quantity affected

583 cartons

Distribution

USA (nationwide) including the states of AL, CA, CO, CT, DC, DE, FL, IA, IL, IN, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA and WI.

Date initiated

2012-08-03

Date posted

2012-11-06

Date terminated

2014-01-15

Location

Newark, DE

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