Z-1739-2011

Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012 This method is an in vitro diagnostic...

Name: Z-1739-2011 Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012 This method is an in vitro diagnostic...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2010-11-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-11-30 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012 This method is an in vitro diagnostic test for the quantitative measurement of... on 2010-11-30. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1739-2011
Status: Terminated
Initiated: 2010-11-30
Posted: 2011-03-21
Terminated: 2013-03-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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.
Product code: LCD Enzyme Immunoassay, Gentamicin
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.
FDA root cause: Other
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.
Quantity in commerce: N/A
Distribution: 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.
Product codes and lots: All Lots

Product code LCD

K062024Class IIDimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin, Theophylline Flex Reagent CartridgeDade Behring, Inc. / cleared 2006-07-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)