Dimension Vista Gentamicin Flex reagent cartridge recall
Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC…
Why was Dimension Vista Gentamicin Flex reagent cartridge recalled?
The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators. The negative bias observed for patient, QC, and calibrator samples, when using any of the listed lots, has the potential to impact the interpretation of gentamicin results during therapeutic monitoring at concentrations up to approximately 2.5 ¿g/mL [5.4 ¿mol/L].
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?
Lots 17135BC 17150BF 17159BD 17178AC 17269BD 17312BB
- Product
- Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 20373
- Distribution
- Nationwide distribution. Foreign distribution to Argentina, Australia, Brazil, Bahamas, Canada, Germany, India, Japan, Myanmar, New Zealand, Saudi Arabia, Taiwan, and South Africa.
- Recall date
- June 20, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)