Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measuremen

FDA device recall Z-0339-2016 · posted 2015-11-25 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6 mg/dL [0.66 mmol/L]; equivalent to a maximum negative bias of -88%.

Action taken

An Urgent Medical Device Recall dated September 2015 was provided to all Dimension Vista MG customers who received the affected lot to notify them of the issue, the potential risk to health, and actions to be taken by customers. 1. An Urgent Medical Device Recall was provided to all customers who received the affected lot to notify them of the following: Siemens has received customer complaints for Dimension Vista MG lot 15063BA, regarding sporadic depressed serum/plasma and QC results. Discontinue use and discard their remaining inventory of the affected lot. Review the letter with their Medical Director. Siemens will replace any unused inventory of the affected lot.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JGJ

Quantity affected

3601

Distribution

Distributed US (nationwide) including DC and the states of IL, CA, GA, LA, TX, TN, FL, SC, IA, TN, DE, NJ, WA, MS, KY, NY, WI, OH, OH, MO, UT, KS, VA, AR, WV, MA, PA, AL, CO, IN, MT, NM, ME, AZ, NM, M

Date initiated

2015-09-30

Date posted

2015-11-25

Date terminated

2016-09-01

Location

Newark, DE

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