Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2182-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 19, 2018

Date Posted: June 20, 2018

Recall Number: Z-2182-2018

Event ID: 80009

Reason for Recall:

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].

Status: Terminated

Product Quantity: 20373

Code Information:

Lots 17135BC 17150BF 17159BD 17178AC 17269BD 17312BB

Distribution Pattern:

Nationwide distribution. Foreign distribution to Argentina, Australia, Brazil, Bahamas, Canada, Germany, India, Japan, Myanmar, New Zealand, Saudi Arabia, Taiwan, and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated