Medical Device Recall: Roche cobas 5800 False Results Due to Baseline Anomalies
Roche Molecular Systems recalls the cobas 5800 PCR testing instrument due to false positive and invalid results caused by anomalous baselines. This may lead to erroneous or delayed diagnoses.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a diagnostic device reporting false positive and invalid results that may cause erroneous or delayed diagnoses. No confirmed illnesses or injuries are mentioned in the source. The severity is High per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Roche Molecular Systems, Inc. is recalling the cobas 5800 instrument (Material No. 08707464001), an automated polymerase chain reaction (PCR) device used for nucleic acid testing in laboratory settings.
The recall was triggered by reports of false positive and invalid results on affected devices due to anomalous baselines. These incorrect results may lead to erroneous diagnoses or delayed test results for patients.
The recall affects 179 units distributed internationally. The affected devices have been distributed to Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Lithuania, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom, Chile, Colombia, Hong Kong, Jamaica, Japan, Nicaragua, Oman, Pakistan, and the United Arab Emirates. All serial IDs are affected.
The recalled product
- Product
- cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
- Manufacturer
- Roche Molecular Systems, Inc.
- Affected units
- 179
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Device Identifier: 07613336170076 All serial IDs are affected.
Distribution
Distribution scope not specified by the agency.
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