—#139174

Product

Dimension Vista B2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.

FDA product code: JZG — System, Test, Beta-2-Microglobulin Immunological
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K083463
Affected lot / code info: Lot Number:15037MA; ExpDate: 2016-07-14 Lot # 15175MA; ExpDate: 2015-11-17; Lot # 15204MA; Expdate: 2017-01-13; Lot #15246MA; expdate: 2017-02-26 Lot # 15267MA; expdate: 2017-02-26

Why it was recalled

customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is the potential for falsely depressed beta2-Microglobulin results on the Dimension Vista system due to assay reagent contamination.

Root cause (FDA determination)

Environmental control

Action the firm took

Siemens sent an Urgent Medical Device Correction letter dated July 2015 to all affected customers. The letter identified the affected product, problem, risk to health, and actions to be taken by customers. For questions contact your Customer Care Center - Technical Solutions at 1-800-441-9250 or your local Siemens technical support representative.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution in the states of TN, AZ, CT, Fl, CA, NY and WI

Timeline

Recall initiated: 2015-07-23
Posted by FDA: 2015-08-22
Terminated: 2017-03-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139174. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.