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Terminated

Dimension Vista LOCI Reaction Vessel

FDA Recall Z-0980-2010 · Posted 2010-03-05

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2009-11-24
Date Terminated2011-09-08
Product Quantity408 units

Reason for Recall

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

Firm Action

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.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051087DIMENSION VISTA INTEGRATED SYSTEMDade Behring, Inc. · 2005-07-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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