Phadia 1000 Instrument, Article Number 12-3800-01.
This recall has been terminated (originally issued July 5, 2017).
- Company
- Phadia Us Inc
- Recall Initiated
- July 5, 2017
- Terminated
- October 4, 2018
- Recall Number
- Z-0387-2018
- Quantity
- 70 units
- Firm Location
- Portage, MI
- Official Source
- View on FDA website ↗
Reason for Recall
The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
Distribution
Nationwide
Lot / Code Info
All versions of the instrument
Root Cause
Device Design
Action Taken
The firm sent letters with a return response form to customers. The firm instructed customers to immediately choose the "stop" command if presented with the 7-101 Liquid Sensor Error. Results from the assay should not be approved. A revision of the current software will have a mandatory installation soon.
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