Agency classClass IIOur severity:High FDA (Devices)·Z-2450-2015·Announced 2015-09-02

Siemens Recalls Dimension Vista B2-Microglobulin Reagent Cartridges

Siemens Healthcare Diagnostics is recalling 1,655 Dimension Vista B2-Microglobulin Flex Reagent Cartridges due to potential reagent contamination that may cause falsely low test results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (falsely depressed diagnostic results) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 1,655 units of the Dimension Vista B2-Microglobulin Flex Reagent Cartridge (B2MIC). The affected lots are 15037MA, 15175MA, 15204MA, 15246MA, and 15267MA. These products were distributed nationwide in the states of Tennessee, Arizona, Connecticut, Florida, California, New York, and Wisconsin.

The recall was initiated because customers reported a high number of abnormal assay errors or were unable to calibrate the B2MIC method. The failure mode involves assay reagent contamination, which creates the potential for falsely depressed beta2-Microglobulin results on the Dimension Vista system. This in vitro diagnostic test is used to measure B2-Microglobulin in human serum, plasma, and urine to aid in the diagnosis of active rheumatoid arthritis and kidney disease.

Healthcare facilities and laboratories using these cartridges should stop using the affected lots and contact Siemens Healthcare Diagnostics for instructions on returning the product. Users should verify their lot numbers against the list provided to determine if their inventory is affected.

The recalled product

Product: Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System.…
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: mis-labeling
diagnostic-error
Affected units: 1,655

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

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

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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