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Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge… recallZ-2175-2012 · Siemens Healthcare Diagnostics, Inc. · initiated Jul 17, 2012

Class III Terminated All recalls posted in August 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-2175-2012
Recall class
Class III
Status
Terminated
Initiated by the company
Jul 17, 2012
Posted by the FDA
Aug 9, 2012
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
1,894 cartons
Product code
LEH
FDA submissions
K061655
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, TN, TX, UT, VA, WA, and WV, and the countries of Canada, New Zealand, Germany, and Puerto Rico.

Product description

Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.

Code information (models, lots, serial numbers)

lot 12095AD, exp 2013-04-04

Other devices under the same FDA submission

6 devices cleared under K061655 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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