ARIES C. difficile Assay recall
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
Why was ARIES C. difficile Assay 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
- Recalling firm
- Luminex Corporation
- Quantity
- N/A
- Distribution
- 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
- Recall date
- August 21, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)