Qiagen Sciences LLC: Medical Device Recall in 2022 - (Recall #: Z-0951-2022)

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:

therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)

Product Classification:

Class II

Date Initiated: February 25, 2022

Date Posted: April 27, 2022

Recall Number: Z-0951-2022

Event ID: 89914

Reason for Recall:

False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.

Status: Ongoing

Product Quantity: 435 kits

Code Information:

All lot numbers. GTIN number: 04053228002048

Distribution Pattern:

AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV

Voluntary or Mandated:

Voluntary: Firm initiated