Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2282-2019·Announced 2019-08-21

Luminex Aries Bordetella Assay Recalled for Partially Sealed Cassette Assemblies

Luminex Corporation is recalling Aries Bordetella Assay kits because partially sealed side cassette assemblies may reduce 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a manufacturing defect that could decrease assay sensitivity or stability, but no specific patient injuries or illnesses are reported in the source text.

Plain-English summary

Luminex Corporation is recalling the Aries Bordetella Assay (REF 50-10037, UDI # 00840487101452) 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 impact of these partial seals 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 lot numbers: AA7125 and AA7310 (discontinue use immediately), AA7548 (discontinue use by 3/13/2019), and AA7633 (discontinue use by 4/12/2019).

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 check their lot numbers and discontinue use of the affected products according to the specified dates.

The recalled product

Product: Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
Manufacturer: Luminex Corporation
Category: Medical Device — In Vitro Diagnostic
Hazard: manufacturing-defect
reduced-sensitivity

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

AA7310 - Immediately
AA7548 - 3/13/2019
AA7633 - 4/12/2019

Distribution

Distributed in 34 states:

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.

See all 7 products in this recall →

Same manufacturer · Luminex Corporation

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