QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Check against the official notice below — it lists the full affected range.
Qiagen Sciences LLC is recalling QIAstat-Dx Respiratory SARS-CoV-2 Panel cartridges from LOT 210209 due to sixteen faulty cartridges that contain incorrect primer-probe mixes in their reaction chambers. These defective cartridges could produce false-negative results, false-positive results, or both types of incorrect results when used for testing. The affected lot was distributed domestically to Alabama, the District of Columbia, Kentucky, Maryland, Maine, New Jersey, Oklahoma, Pennsylvania, and Texas, with a total of 376 kits involved in the recall.
The recalled cartridges can be identified by LOT 210209 and the sixteen specific serial numbers listed in the recall notice (412092551 through 412092567). The source document does not specify what actions affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution. Quantity: 376 kits Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.