Recall Z-2286-2019— Luminex Corporation
Class II · Ongoing
Class II FDA medical device recall by Luminex Corporation, initiated 2019-02-20. It names one FDA 510(k) clearance: K172402. Product: ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469. Reason: 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..
- Recalling firm
- Luminex Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-02-20
- Firm location
- Austin, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.