FDA Device recall Z-2182-2018

Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay

• FDA Device
• Class II
• terminated
• Published 2018-06-20

On 2018-06-20 the FDA classified a Class II recall of Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay by Siemens Healthcare Diagnostics, citing the affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not s….

Read the official FDA Device notice

Product

Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB.

Reason

The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators. The negative bias observed for patient, QC, and calibrator samples, when using any of the listed lots, has the potential to impact the interpretation of gentamicin results during therapeutic monitoring at concentrations up to approximately 2.5 ¿g/mL [5.4 ¿mol/L].

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2182-2018%22

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