Dimension Vista Digoxin recall
Dimension Vista Digoxin (DIGXN) Flex reagent cartridge
Why was Dimension Vista Digoxin recalled?
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
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?
Device Listing Number # D098364 Lot # 16103BD, 16195BB, 16230BA, 16259BD, 16320BD, 16363BA
- Product
- Dimension Vista Digoxin (DIGXN) Flex reagent cartridge
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 13,143 units
- Distribution
- Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa
- Recall date
- June 28, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)