CLASS II ONGOING Device recall · Reported 21 Aug 2019 · FDA Enforcement Report
Aries C. difficile Assay recalled by Luminex
Luminex is recalling Aries C. difficile Assay, distributed in 34 states. The recall was initiated on 20 Feb 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2287-2019
- FDA event ID
- 83470
- Recalling firm
- Luminex, Austin, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Feb 2019
- FDA classified
- 15 Aug 2019
- Reported
- 21 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Feb 2019 | Recall initiated by company | |
| 15 Aug 2019 | Classified by FDA | +176 days |
| 21 Aug 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
Where it was distributed
US: AK, AL, AZ,CA,CO,FL,GA,IL,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,NE,NJ,NM,NY,OH,ON,OR,PA,TN,TX,UT,VA,VT,WA,WI, OUS: Belgium, Canada, Thailand, Germany, Singapore, United Kingdom
AlaskaAlabamaArizonaCaliforniaColoradoFloridaGeorgiaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouriMississippiMontanaNorth Carolina
Questions about this recall
Is Aries C. difficile Assay recalled?
Yes. Luminex recalled Aries C. difficile Assay on 20 Feb 2019. The recall is Class II and its status is Ongoing. Recall number Z-2287-2019.
Why was it recalled?
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Which lots are affected?
Lot numbers & discontinue use by dates for Part Number 50-10018 AA7306 - Immediately; AA7311 - 2/27/2019; AA7627 - 3/28/2019; AA7634 - 4/3/2019
Where was it sold?
US: AK, AL, AZ,CA,CO,FL,GA,IL,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,NE,NJ,NM,NY,OH,ON,OR,PA,TN,TX,UT,VA,VT,WA,WI, OUS: Belgium, Canada, Thailand, Germany, Singapore, United Kingdom
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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