Recalls / —

—#87271

Product

Dimension Vista LOCI Reaction Vessel

FDA product code

JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Device class

Class 1

Medical specialty

Clinical Chemistry

510(k) numbers

K051087

Affected lot / code info

Catalog number KS855. Lot number NH29-188-09

Why it was recalled

Some vessels may leak. If leakage occurs, patient results will be flagged and are not reportable.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The recalling firm issued an Urgent Field Safety Notice dated 11/2009 to all affected customers. Customers have been told to discard any bags of the affected lot. If the affected lot is the only lot the customer has, customers can examine a vessel from the bag. If the vessel mold cavity identity is B8, customers should discard the bag. Thus customers can use the lot if the cavity mold is anything other than B8. In addition, customers have been told to empty the LOCI vessel holder on all systems and to discard vessels in case any affected vessels have been loaded onto the system. For technical questions or concerns, please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance.

Recalling firm

Firm

Siemens Healthcare Diagnostics, Inc.

Address

500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern

The device was shipped to medical facilities in CA, CO, FL, GA, IL, LA, MD, MI, MS, NE, NC, NJ, NY, OH, SC, TN, TX, VA, WA, and WI. The product was also shipped to Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, and Switzerland.

Timeline

Recall initiated

2009-11-24

Posted by FDA

2010-03-05

Terminated

2011-09-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #87271. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.