cobas 5800 instrument recall
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory…
Why was cobas 5800 instrument recalled?
Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Device Identifier: 07613336170076 All serial IDs are affected.
- Product
- cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory…
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 179 OUS
- Distribution
- International distribution in the countries of Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Lithuania, Poland, Portugal, Spain, Sweden, Switzerland, UK, Chile, Colombia, Hong Kong, Jamaica, Japan, Nicaragua, Oman, Pakistan, UAE.
- Recall date
- October 26, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)