The Recall Desk
HighFDA (Devices)·Z-1746-2022·Announced 2022-09-21

Laboratory device displays incorrect sample volume guidance during setup

A laboratory automation device's setup screen indicates minimal volume when the exact volume should be loaded, potentially causing over-diluted, under-diluted, or improperly prepared samples and false test results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a risk-of-harm product (false test results from improper sample preparation) where injury has not yet been reported. Per the severity rubric, this meets the criteria for High (3).

Plain-English summary

The QIAcube Connect MDx (Model 9003070) is a laboratory automation device for sample preparation. During the 'Load tip racks and enzymes' setup step, the device's information screen displays a message about 'minimal volume to be loaded,' but the volume value shown is actually the exact volume that must be loaded. This can cause users to misunderstand whether to load minimal or exact volumes.

Incorrect sample volumes lead to over-diluted, under-diluted, or improperly lysed samples, which can cause false negative or false positive test results. Affected units have been distributed to facilities throughout the United States and internationally.

If you operate one of these devices, contact Qiagen Sciences LLC to clarify proper loading volumes and verify your setup procedures to ensure accurate sample preparation.

The recalled product

Product
QIAcube Connect MDx, Model No. 9003070
Manufacturer
Qiagen Sciences LLC
Category
Medical Device — Laboratory Equipment
Hazard

Distribution

Distributed in 26 states:

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