FDAJanuary 28, 2020device
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the calculated concentration result value as a logarithmic value, and could lead to a false negative result, which could lead to serious medical consequences such as the suspension or non-initiation of treatment
What to do
FDA enforcement status: Terminated
Brands named
qiagen sciencesqiagen
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAArtelon FlexBand Dynamic Matrix Ref: 310572026-02-06
- FDAArtelon FlexBand Plus Ref: 41054 & 410572026-02-06
- FDAFemiClear Daily Bladder Strength Dietary Supplement, 28 Count, UPC 817008020684, SKU FEM500602025-09-04
- FDA4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)2025-07-30
- FDABZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-012025-07-22
- FDABD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD2025-07-08
- FDABD Trucount Controls, 30 Test - REF: 3403352025-07-08
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