Recall Z-0097-2023 ยท NSU Instrumentation For Clinical Multiplex Test Systems
Roche Molecular Systems, Inc.
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
| Date | Oct 17, 2022 (initiated Sep 8, 2022) |
| Status | Terminated |
| Reason | Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses. |
| Root cause | Under Investigation by firm |
| Action | On September 8, 2022, the firm notified all affected customers via an Urgent Field Safety Notice letter. Customers were informed that the issue was attributed to WAKO lenses with a deposit on their surfaces, which can affect the signal in the detection unit. Roche will retrieve and analyze customer's cobas 5800 run data. If the evaluation determines that a lens cleaning is warranted, a service visit will be scheduled. If a lens cleaning is not warranted, no further actions are required. Customers should follow laboratory standard operating procedures to investigate the potential for false po |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.