Recall Z-0446-2019 ยท PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
BioFire Diagnostics, LLC
-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic
| Date | Sep 10, 2018 |
| Status | Terminated |
| Reason | Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected. |
| Root cause | Material/Component Contamination |
| Action | On 09/10/2018, the firm sent an Urgent Medical Device Recall Letter via FedEx to the Recall Coordinator/Laboratory Director for all consignees. Consignees are instructed to: -Immediately examine their inventory for products with the affected Lot numbers and to discontinue use and to discard any remaining product in their possession that is subject to the recall.. BioFire will replace discarded product at no charge. -If the consignee has further distributed the affected product, they are to identify these customers and to notify them at once of the product recall. -Complete and return the Ackn |
| Quantity | 1350 pouches |
| Distribution | Worldwide Distribution - US Nationwide in the states of: CA DC, FL, IN, KY, MN, MO, NB, NJ, OH, TX and WI. International: Canada, Columbia and Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.