On 30 December 2020, QIAGEN issued an Urgent Field Safety Notice regarding a batch of their Covid tests: “In some cartridges, the reaction chamber that should hold the reaction mix for the SARS-CoV-2 target falsely contains the mix for atypical bacteria targets Mycoplasma pneumoniae, Legionella pneumophila, and Bordetella pertussis, and vice versa.”
It is the first on a rolling list of field safety notices (“FSNs”) from medical device manufacturers published since January 2020. The list of FSNs is maintained by the Medicines and Healthcare products Regulatory Agency (“MHRA”). In the document below we filtered MHRA’s full list as of 31 December 2021 for device descriptions that contained the word “SARS”. There are 24 FSNs relating to “SARS” devices, 15 of them specifically to PCR Tests and at least one relates to a lateral flow antigen test.
QIAGEN has issued five FSNs over the last 12 months.
QIAGEN is a German provider of sample and assay technologies for molecular diagnostics, applied testing, academic and pharmaceutical research. Consolidated under the Dutch holding QIAGEN N.V., the company operates more than 35 offices in over 25 countries. “We are proud to serve over 500,000 customers around the globe with QIAGEN’s Sample to Insight solutions … QIAGEN’s products are found in nearly every lab the world over,” their website states.
In March 2020, QIAGEN or QGEN announced that it was working to develop a QIAstat-Dx test kit to distinguish the novel SARS-CoV-2 coronavirus from 21 other serious respiratory infections. Per QIAGEN, it was partnering with customers and public health authorities globally to scale up its coronavirus testing capacity, and “make available the Sample to Insight QIAstat-Dx respiratory panel with SARS-CoV-2 detection.”
On 30 December 2020, QIAGEN recalled a batch of their “QIAstat-Dx Respiratory SARS-CoV-2 Panel, REF 691214”, which enables detection of the SARS-CoV-2 virus, as it was “faulty.” The Panel was faulty because instead of containing the reaction mix for detecting SARS-CoV-2 it held the mix for detecting atypical bacteria. One of the atypical bacteria the test was detecting, instead of Covid, was Mycoplasma pneumoniae – an important cause of upper respiratory tract infection and bronchitis/pneumonia, usually as sporadic infections or outbreaks through human-to-human transmission among families or in closed environments.
“False results could lead to incorrect treatment decisions that could set off adverse events linked to the nature of the treatment (i.e., use of antibiotics/antivirals),” QIAGEN’s FSN states, “if you have remaining stock of LOT 200218, REF 691214, do not use it … If you already used cartridges from this LOT, please identify the results obtained.”
We have attached a copy of QIAGEN’s Urgent Field Safety Notice dated 30 December 2020 below.
In July 2020, the US Food and Drug Administration (“FDA”) issued a Class 2 recall of the same QIAGEN Panels but in this instance it was due to false positive PCR tests for Influenza A. The FDA recommended that positive results for flu A “should be retested with an alternate method and interpreted in the context of current epidemiology and clinical presentation.”
There is no indication how many Covid tests were in the batch being recalled at the end of December 2020, which countries or suppliers received products from this particular batch, how many had already been used to “diagnose Covid cases” and whether all suppliers stopped using the “false” tests. But we cannot help wondering if any of these “false” results were included in BBC’s daily count of “Covid cases” and if so, how many?
And why was this recall not publicised so the public were aware of the problem at the time? It’s almost as if monitoring true cases of Covid to “stop the spread” is not really all that important.
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