—#111801

Product

Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

FDA product code: LPS — Urinary Homocystine (Nonquantitative) Test System
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K063206
Affected lot / code info: Lot numbers 12062MA, exp 12/01/2012; and 12066MA, exp 12/05/2012

Why it was recalled

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

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-08-03
Posted by FDA: 2012-11-06
Terminated: 2014-01-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111801. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.