Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012 This method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
FDA Recall Z-1739-2011 · Posted 2011-03-21
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeLCD
Date Initiated2010-11-30
Date Terminated2013-03-19
Product QuantityN/A
Reason for Recall
False elevation of Dimension Vista(R) Gentamicin results for patients and QC when prior reagent aspirated by the reagent probe is any of the following plasma protein methods: ASL, B2MIC, B2MU, CRP,CYSC, HCYS, hcCRP, IGE, IGG3, IGG4, RF, and STFR resulting in inappropriate patient treatment.
Firm Action
Siemens Healthcare Diagnostics, Inc. sent an Urgent Field Safety Notice letter dated November, 2010, to all affected customers. Customers were requested to run GENT on a Dimension Vista(R) system that does not run the listed plasma protein methods. Instructions were provided for disabling methods on the instrument to prevent inadvertently testing Gent along with plasma protein methods.
Customers were instructed to :
Forward the notification to anyone to whom they may have distributed the product.
Complete and return the Field Correction Effectiveness Check Form to Siemens Healthcare Diagnostics at (302) 631-8467.
For further information contact Siemens Technical Solutions Center at 1-800-441-9250 or their local Siemens representative.
Root Cause
Other
Distribution Pattern
Nationwide Distribution including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.