Recall Z-0301-2027 ยท JJH Clinical Sample Concentrator
BioMerieux SA
EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automated
| Date | Oct 27, 2026 (initiated Sep 11, 2026) |
| Status | Open, Classified |
| Reason | Delayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error, Error 10003 Heater timeout after updating to recent firmware SP4 Patch 2 |
| Root cause | Software change control |
| Action | The firm began notifying consignees on September 11, 2026. Customers were informed they may continue use of EMAG systems and there is no risk of false results. In case of 10003 error heater time-out during an extraction protocol, customers are instructed to reset the system to run the protocol again to prevent delay/loss of sample. The company will contact customers to schedule a bioMerieux Field Service Engineer (FSE) visit to update affected EMAG systems to the previous firmware patch SP4 Patch 1 to fix the issue. |
| Quantity | 33 |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, IN, KS, LA, MN, MO, NY, OH, and TX. The countries of Canada, United Kingdom, Sweden, France, Norway, Netherlands, Belgium, Denmark, Germany, Austria. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.