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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista Gentamicin Flex reagent cartridge

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  Class 2 Device Recall Dimension Vista Gentamicin Flex reagent cartridge see related information
Date Initiated by Firm April 19, 2018
Create Date June 13, 2018
Recall Status1 Terminated 3 on April 24, 2020
Recall Number Z-2182-2018
Recall Event ID 80009
510(K)Number K962819  K062024  
Product Classification Enzyme immunoassay, gentamicin - Product Code LCD
Product Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and
Code Information Lots 17135BC 17150BF 17159BD 17178AC 17269BD 17312BB 
Recalling Firm/
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
Po Box 6101
Newark DE 19702-2466
For Additional Information Contact
Manufacturer 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. 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].
FDA Determined
Cause 2
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 20373
Distribution Nationwide distribution. Foreign distribution to Argentina, Australia, Brazil, Bahamas, Canada, Germany, India, Japan, Myanmar, New Zealand, Saudi Arabia, Taiwan, and South Africa.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LCD and Original Applicant = DADE BEHRING, INC.
510(K)s with Product Code = LCD and Original Applicant = DADE INTL., INC.