Agency classClass IIOur severity:High FDA (Devices)·Z-2181-2018·Announced 2018-06-20

Siemens Recalls Dimension Gentamicin Flex Reagent Cartridges Due to Inaccuracy

Siemens Healthcare Diagnostics is recalling specific lots of Dimension Gentamicin Flex reagent cartridges because they may produce inaccurate test results at the low end of the measurement range.

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 FDA classified this as a Class II recall, which falls under the 'High' severity category in the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 7,543 units of Dimension Gentamicin Flex reagent cartridges, specifically lots EB8115, BB8159, and FB8275. The recall is due to a calibration issue where the curve does not show proper separation between Level 1 and Level 2 calibrators. This defect may cause inaccuracy in Quality Control and patient samples at the low end of the Analytical Measurement Range.

The affected products were distributed nationwide and in foreign markets including Argentina, Australia, Brazil, the Bahamas, Canada, Germany, India, Japan, Myanmar, New Zealand, Saudi Arabia, Taiwan, and South Africa. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

Healthcare facilities and laboratories should stop using the affected lots immediately. Users should contact Siemens Healthcare Diagnostics for instructions on returning the product or obtaining replacements. Patients who have had gentamicin levels tested using these specific lots should consult their healthcare provider to discuss the potential impact on their test results.

The recalled product

Product: Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
inaccurate-results
Affected units: 7,543

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 (1)

Lots EB8115 BB8159 FB8275

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · mis labeling