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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista B2 Microglobulin Flex Reagent Cartridge

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 Class 2 Device Recall Dimension Vista B2 Microglobulin Flex Reagent Cartridgesee related information
Date Initiated by FirmNovember 03, 2015
Date PostedMarch 01, 2016
Recall Status1 Terminated 3 on January 13, 2017
Recall NumberZ-1030-2016
Recall Event ID 73080
510(K)NumberK083463 
Product Classification System, test, beta-2-microglobulin immunological - Product Code JZG
ProductDimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA 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.
Code Information Lot #: 15037MA - foreign 15175MA - foreign 15204MA- foreign 15246MA (Distributed in US) 15267MA - foreign 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact
800-441-9250
Manufacturer Reason
for Recall		Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors and calibration failures with the Dimension Vista B2MIC Flex reagent cartridge: Dimension Vista System Flex reagent cartridge and urine stabilizer B2MIC. In the unlikely event that a patient result is generated, a suppressed result would be in conflict with the patients clinical status and other markers of renal injury.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionSiemens sent an Urgent Medical Device Recall dated November 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use and discard your remaining inventory of the affected product. Indicate your replacement product needs on the attached Field Correction Effectiveness Check Form and return. For questions call Siemens Customer Care Center- Technical Solutions at 800-441-9250 or your local Siemens technical support representative.
Quantity in Commerce1637 units.
DistributionWorldwide Distribution and US in the state of CA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JZG
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