—#90370

Product

Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS855. For in vitro diagnostic use.

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: Lot numbers NH20-309-09, NH20-330-09, NH20-337-09, and NH20-001-10

Why it was recalled

Vessel pick up errors and vessel jams when the vessel is being loaded. The error halts the instrument and disrupts processing. Vessel flange is thin.

Root cause (FDA determination)

Process design

Action the firm took

Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice dated March 2010 informing users of the potential problem, to discard any remaining product, and if needed, to request a replacement lot.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: Worldwide distribution: USA, Canada, Europe, Japan, Korea, and New Zealand.

Timeline

Recall initiated: 2010-03-15
Posted by FDA: 2010-08-02
Terminated: 2010-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90370. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.