Roche recalls cobas 5800 PCR instruments with Material No. 08707464001 due to reported false positives and invalid results, potentially causing delayed diagnoses.
Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
Roche is recalling cobas 5800 PCR instruments with specific serial numbers because they may produce false positive results, which could lead to incorrect diagnoses and delayed treatment.
The affected devices may show false positive results due to anomalous baselines, which can cause incorrect diagnoses and delayed treatment of conditions. This issue occurs in laboratory settings where the devices are used for PCR-based nucleic acid testing.
Laboratory users who own or operate the affected cobas 5800 instruments with serial numbers starting with 07613336170076. Medical professionals and labs using these devices are most at risk.
Check for the device serial number starting with 07613336170076. The affected model is the cobas 5800 instrument with Material No. 08707464001.
Look for the serial number starting with 07613336170076 on the cobas 5800 instrument.
The recall is due to reported false positive and invalid results on the affected devices, which may lead to erroneous or delayed diagnoses.
Check the device serial number starting with 07613336170076. If affected, contact Roche for further instructions.
The recall record does not mention a specific remedy or fix.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0097-2023 — Roche Roche Hello, I own a Roche that is covered by recall Z-0097-2023 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
