Dimension Vista Enzymatic Creatinine recall
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
Why was Dimension Vista Enzymatic Creatinine recalled?
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
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?
UDI Number: 00842768036262 Lots: All lots
- Product
- Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 11,725 units
- Distribution
- US Nationwide
- Recall date
- February 26, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)