Siemens Dimension Vista(R) System Vista Drug 4 recall
Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
Why was Siemens Dimension Vista(R) System Vista Drug 4 recalled?
Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot 2KD053. Internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number KC460, SMN 10472284, lot 2KD052, exp 5/1/14 and Catalog Number KC460A, SMN 10476471, lot 2KD053, exp 5/1/14.
- Product
- Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1,638
- Distribution
- Distributed within the US to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
- Recall date
- April 24, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)