Qiagen Sciences LLC: Medical Device Recall in 2022 - (Recall #: Z-1652-2022)

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:

FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010

Product Classification:

Class II

Date Initiated: July 20, 2022

Date Posted: September 7, 2022

Recall Number: Z-1652-2022

Event ID: 90691

Reason for Recall:

Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects

Status: Ongoing

Product Quantity: 9 kits

Code Information:

Lot number: 169047135 Exp Date: 12.06.2022 172017806 Exp. Date: 10.11.2022

Distribution Pattern:

IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand

Voluntary or Mandated:

Voluntary: Firm initiated