Recalls / —
—#164205
Product
Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
- FDA product code
- LCD — Enzyme Immunoassay, Gentamicin
- Device class
- Class 2
- Medical specialty
- Clinical Toxicology
- 510(k) numbers
- K062024, K962819
- Affected lot / code info
- Lots EB8115 BB8159 FB8275
Why it was recalled
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 (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 500 Gbc Dr Po Box 6101, Ms 514, Newark, Delaware 19702-2466
Distribution
- Distribution pattern
- Nationwide distribution. Foreign distribution to Argentina, Australia, Brazil, Bahamas, Canada, Germany, India, Japan, Myanmar, New Zealand, Saudi Arabia, Taiwan, and South Africa.
Timeline
- Recall initiated
- 2018-04-19
- Terminated
- 2020-04-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #164205. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.