Qiagen Sciences LLC: Medical Device Recall in 2023 - (Recall #: Z-1683-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

Product Classification:

Class II

Date Initiated: April 28, 2023

Date Posted: June 14, 2023

Recall Number: Z-1683-2023

Event ID: 92298

Reason for Recall:

Faulty cartridges in the lot could result in false test results.

Status: Ongoing

Product Quantity: 347 kits

Code Information:

GTIN 14053228038846; Lot 175011350; Serial Numbers within the range of 330568064 to SN 330568597 AND 330569655, 330569651, 330569650, 330569646, 330569645, 330569644, 330569643, 330569641.

Distribution Pattern:

US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.

Voluntary or Mandated:

Voluntary: Firm initiated