Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2181-2018)

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 Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.

Product Classification:

Class II

Date Initiated: April 19, 2018

Date Posted: June 20, 2018

Recall Number: Z-2181-2018

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.

Status: Terminated

Product Quantity: 7543

Code Information:

Lots EB8115 BB8159 FB8275

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