Z-2181-2018Class II

Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are...

Name: Z-2181-2018 Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2018-04-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-04-19 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275 on 2018-04-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2181-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-19
Posted: 2018-06-13
Terminated: 2020-04-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
Product code: LCD Enzyme Immunoassay, Gentamicin
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On April 19, 2018, the firm sent an Urgent Medical Device Recall letter to customers. The letter identified the affected lots and advised customers to do the following: Inspect stock, discontinue use of and discard the Dimension and Dimension Vista GENT lots listed in Table 1. Please review this letter with your Medical Director. Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the regulatory authorities. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens Technical Support Representative.
Quantity in commerce: 7543
Distribution: Nationwide distribution. Foreign distribution to Argentina, Australia, Brazil, Bahamas, Canada, Germany, India, Japan, Myanmar, New Zealand, Saudi Arabia, Taiwan, and South Africa.
Product codes and lots: Lots EB8115 BB8159 FB8275

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2181-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2181-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-13
Z-2182-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-13

Product code LCD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)