Dimension Vista Enzyme 1 Calibrator recall
Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase…
Why was Dimension Vista Enzyme 1 Calibrator recalled?
Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL).
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?
lot 3FD034, exp. 6/17/2014, and lot 3HD012, exp. 9/1/2014.
- Product
- Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 3496
- Distribution
- Nationwide Distribution.
- Recall date
- March 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)