Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of van

FDA device recall Z-2175-2012 · posted 2012-08-09 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay from being run on the Dimension Vista(R) System.

Action taken

The firm initiated their recall of this product on July 17, 2012 by sending an Urgent Field Safety Notification via FedEx next day delivery to all consignees. The Notice informed consignees of the high calibration slopes with the affected device. Affected consignees were requested to immediately discontinue use and discard any remaining Dimension Vista(R) VANC Flex(R) reagent cartridges, lot 12095AD. Affected customers were provided with replacement cartridges. Customers were to also complete the attached form and fax it back to the number provided. The notification letter should be forwarded to anyone, whom customers may have further distributed the affected lot. Questions and concerns should be directed to Siemens Technical Solutions Center at 800-441-9250.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LEH

Quantity affected

1,894 cartons

Distribution

Worldwide Distribution -- US, including Washington, DC and the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC,

Date initiated

2012-07-17

Date posted

2012-08-09

Date terminated

2014-01-14

Location

Newark, DE

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