FDA Device

Phadia 1000 Instrument, Article Number 12-3800-01.

Hazard

The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.

What You Should Do

Remedy

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.

Products

Phadia 1000 Instrument, Article Number 12-3800-01.
Brand
Phadia US Inc
UPC
All versions of the instrument

Units Affected

70 units