openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
-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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
ME Panel Kit Lot No. ME Pouch Lot. No. Kit Expiration Date 580818 892018 4/2/2019 584418 896018 4/5/2019 Note - Kits contain a Primer Pill Lot 210318. The Primer Pill is a freeze dried/lyophilized "pellet" that contains all of the primers and buffer used in the PCR1 reaction.
Distribution pattern
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
