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Photo: Carsten Rehder / picture alliance / dpa
Rapid corona tests from the manufacturer Genrui led to great resentment in schools in Hamburg: According to the school senate, 19 of 20 positive results were wrong in individual cases.
The PCR test showed that there was no Covid infection at all.
For months, the manufacturer apparently let the criticism roll off – now he has officially admitted that at least some of the tests are faulty.
The Senate announced on Tuesday that the Genrui company had admitted that contamination during production was the cause of countless false-positive test results.
"The distributor of the Genrui rapid tests has informed the city that the manufacturer has published a product recall of two batches of the 'Genrui SARS-CoV-2 Antigen Test Kit (Colloidal Gold)' for the German market," the letter reads the city.
The reason given by the manufacturer was therefore frequent false-positive results.
According to the city, two batches are affected.
One of them was also delivered to Hamburg from October 2021.
The Genrui company stated that the reliability of negative results was not affected by the error.
Infections were therefore recognized.
Senate is considering legal action
School Senator Ties Rabe (SPD) gave free rein to his indignation at the type of communication.
"The faulty tests caused millions of dollars in costs and scared countless school communities and families with false corona reports," he said in a letter to SPIEGEL.
“It is incomprehensible to me that after these huge problems the manufacturer just sent a brash e-mail all over the world without trying to make amends and claim damages.” The Hamburg Senate is now examining legal action.
The Hanseatic city had received around four million quick tests of the faulty batch.
Most of these have already been delivered or used.
According to the information, the remaining stocks are still in the warehouse, which have now been blocked.
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In total, the Hanseatic city has procured almost twelve million tests from Genrui, of which around four million have been used in schools.
According to the city's statement, the Genrui test was rated well by the Paul Ehrlich Institute, among others.
However, as early as autumn, when the rapid tests were used in Hamburg, it was noticeable that they often reported an infection that was not confirmed by the PCR test.
At one school alone, the Christianeum in western Hamburg, there were around a hundred false-positive results within a week.
According to Rabe, the false positive results would have had massive consequences for the affected students and their families.
Children had to be isolated and picked up by their families, only after a negative PCR test could they go back to school.
In view of the weeks of trouble and the many hardships and problems in the families and school communities, the senator said that one would not be satisfied with "a succinct e-mail" from the manufacturer.
In the absence of alternative tests, Genrui tests continued to be used in schools until at least January 10, according to the School Senate.
The defective tests are no longer used, instead tests from Siemens Healthcare, which work much better, have been used for weeks.
According to the school senate, no decision has yet been made about a possible future use of Genrui residues that do not belong to the defective batches, especially because the defective tests would of course have to be sorted out first.
Raven isn't the only one upset.
There is also great dissatisfaction with some Hamburg daycare parents – because, in their opinion, the error-prone tests were still being used in daycare centers for far too long, well into January.
Social Welfare still used stocks
The Senate Department for Social Affairs, which is responsible for daycare centers, explained that all facilities had previously been supplied with the tests procured by the city.
Among them was the Genrui product in a delivery at the end of October/beginning of November – and most recently the Siemens product, which has been procured since December.
“Inventory stocks are gradually being used, so that in the past few months the Genrui product has been used in some deliveries and the Siemens product in some cases,” reports the social security authority.
The Genrui tests were apparently still being used in Hamburg daycare centers, even though those responsible knew that there had been many problems with them at the schools.
It is unclear how extensively they were used and whether the tests came from the faulty batch. »Elbkinder« is one of the largest day care providers in Hamburg. The management reports that most of the tests that have now been recalled have not yet been sent to the daycare centers. In the event that individual test kits from this batch should be in stock in the daycare centers, the daycare centers were asked immediately after the recall became known to only use the Siemens tests that were already predominantly distributed and used.
And the social authorities also reacted unequivocally after the recall. In a circular, she called on all parents of daycare children in Hamburg to stop using tests from the recalled Genrui batch. It cannot be ruled out with certainty »that you were supplied with tests from the faulty batch last year. [...] Ask your day-care center to issue new tests.«
Other countries had already taken action earlier: According to the national regulatory authority HRPA, consumers in Ireland have already submitted more than 1,350 reports of false-positive Genrui tests.
The HRPA then withdrew two test batches from the market on January 18 - and recommended that the Genrui rapid tests no longer be offered at all.
Affected consumers should return the tests, it said.
Genrui temporarily stopped selling his tests in Ireland himself.
Spain's drug agency AEMPS had already asked retailers on January 9 to withdraw all Genrui rapid tests and stop selling the products because of the suspicion of numerous false-positive results.
To this end, the AEMPS initiated an investigation into these rapid tests.
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