Z-2181-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 20, 2018
- Initiation Date
- April 19, 2018
- Termination Date
- April 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7543
Product Description
Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
Reason for Recall
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.
Distribution Pattern
Nationwide distribution. Foreign distribution to Argentina, Australia, Brazil, Bahamas, Canada, Germany, India, Japan, Myanmar, New Zealand, Saudi Arabia, Taiwan, and South Africa.
Code Information
Lots EB8115 BB8159 FB8275