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[Recalled] Phadia 1000 Instrument, Article Number 12-3800-01. — The "Retry" command does not function properly which could cause a shortage of… | FDA 2017-07-05

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductPhadia 1000 Instrument, Article Number 12-3800-01.
Brand / manufacturerPhadia US Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0387-2018
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date05 July 2017

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Phadia US Inc

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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