—#164206

Product

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

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

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. 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].

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 #164206. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.