Qiagen Sciences LLC: Medical Device Recall in 2022 - (Recall #: Z-0455-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 8, 2021

Date Posted: January 12, 2022

Recall Number: Z-0455-2022

Event ID: 89130

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.

Status: Terminated

Product Quantity: 376 kits

Code Information:

LOT 210209 UDI (01)14053228038846(17)211127(10)210209(24)691223 Serial Numbers: 412092551 412092559 412092552 412092560 412092553 412092561 412092554 412092563 412092555 412092564 412092556 412092565 412092557 412092566 412092558 412092567

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated