-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 acid-based in vitro diagnostic test intended for use with FilmArray systems.

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.

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 Acknowledgement of Receipt Form that was enclosed with the Customer Advisory Notice letter, as soon as possible, and to return the Acknowledgement Form to the firm. Consignees were provided with firm contact information including phone numbers: 801-736-6354 and 1-800-735-6544