Luminex ARIES GBS Assay Recalled for Partially Sealed Side Cassettes
Luminex Corporation is recalling ARIES GBS Assay kits because partially sealed side cassettes may cause decreased assay sensitivity or stability.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (decreased assay sensitivity/stability) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Luminex Corporation is recalling ARIES GBS Assay kits (REF 50-10021, UDI # 00840487100165) due to a manufacturing defect. An internal investigation revealed that a portion of the side cassette assemblies (SCAs) had back side seals (BSS) that did not meet design specifications, resulting in partially sealed units.
The partial seal could result in a potential decrease in the volume of each solution within the SCAs. This defect may lead to decreased sensitivity or stability of the assay. The recall affects specific lots with the following discontinue use by dates: AA7546 (3/9/2019) and AA7629 (4/10/2019).
The affected products were distributed in the United States (including 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) and internationally in Belgium, Canada, Thailand, Germany, Singapore, and the United Kingdom. Users should discontinue use of the affected lots and contact Luminex Corporation for further instructions.
The recalled product
- Product
- ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
- Manufacturer
- Luminex Corporation
Distribution
Part of a larger recall action
This product is one of 7 recalled by Luminex Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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