Siemens Gentamicin Reagent Cartridge Recall Due to Low-End Inaccuracy
Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Gentamicin Flex reagent cartridges because they may produce inaccurate results at low concentrations.
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 involves a risk-of-harm product (medical diagnostic) where the hazard is potential misinterpretation of results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 20,373 units of Dimension Vista Gentamicin Flex reagent cartridges (DV GENT, gentamicin enzyme immunoassay). The affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB. These products were distributed nationwide and to several foreign countries, including Argentina, Australia, Brazil, the Bahamas, Canada, Germany, India, Japan, Myanmar, New Zealand, Saudi Arabia, Taiwan, and South Africa.
The recall is due to a potential inaccuracy in Quality Control and patient samples at the low end of the Analytical Measurement Range. This issue is caused by the calibration curve not showing separation between the Level 1 and Level 2 calibrators. The resulting negative bias in patient, QC, and calibrator samples could impact the interpretation of gentamicin results during therapeutic monitoring at concentrations up to approximately 2.5 µg/mL [5.4 µmol/L].
Healthcare facilities and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 20,373
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 17135BC 17150BF 17159BD 17178AC 17269BD 17312BB
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.
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