FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
- Recall number
- Z-2181-2018
- 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.
- Status
- Terminated
- Initiated
- 2018-04-19
- Posted
- not on file
- Terminated
- 2020-04-24
- 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.
- 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
- 7543
- Distribution
- Nationwide distribution. Foreign distribution to Argentina, Australia, Brazil, Bahamas, Canada, Germany, India, Japan, Myanmar, New Zealand, Saudi Arabia, Taiwan, and South Africa.
- Lot, serial or model codes
- Lots EB8115 BB8159 FB8275
- 510(k) numbers
- ["K062024","K962819"]
- PMA numbers
- not on file
- Product code
- LCD
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28