FDA recall Z-0455-2022

Product

QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

Reason for recall

The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.

Distribution

Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution.

Key facts

Status

Terminated

Initiation date

2021-11-08

Report date

2022-01-12

Termination date

2023-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Germantown, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0455-2022