Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0455-2022

November 08, 2021

Class II

Product summary

Firm
Qiagen Sciences LLC
Event
Event 89130
Status
Terminated
Classification
Class II
Quantity
376 kits
Official record key
device-enforcement:Z-0455-2022

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.