Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 21, 2018
-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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
BioFire Diagnostics, LLC recalled -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF R… - a moderate-severity action.
-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF R… was recalled by BioFire Diagnostics, LLC in November 21, 2018. Reason: Firm identified an issue in the manufacturing process which might contribute to elevated rates of false posit…. Check the official notice for the remedy. Verify recall #Z-0446-2019 with the FDA Devices before acting.
The recall
BioFire Diagnostics, LLC issued this moderate-severity FDA Devices recall-Firm identified an issue in the manufacturing process which might contribute to elevated rates of false posit….
- Moderate
- severity level
- Class II
- classification
- November 21, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0446-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0446-2019) was formally reported on November 21, 2018, with the manufacturer initiating the action on September 10, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. BioFire Diagnostics, LLC is listed as the recalling firm, operating out of Salt Lake City, UT. Federal records list the affected scope as 1350 pouches.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1350 pouches
Related Recalls
6
0 from same agency
Product description
-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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0446-2019 |
| Date reported | November 21, 2018 |
| Date initiated | September 10, 2018 |
| Recalling firm | BioFire Diagnostics, LLC |
| Firm location | Salt Lake City, UT |
| Affected scope | 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0446-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
-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.. Recalled by BioFire Diagnostics, LLC. Units affected: 1350 pouches.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 21, 2018. Severity: Moderate. Recall number: Z-0446-2019.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0446-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 21, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.