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

FDA device recall Z-1739-2011 · posted 2011-03-21 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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.

Action taken

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

Status

Terminated

Product code

LCD

Quantity affected

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

Date initiated

2010-11-30

Date posted

2011-03-21

Date terminated

2013-03-19

Location

Newark, DE

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