Recall Z-2285-2019 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Luminex Corporation
ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
| Date | Aug 15, 2019 (initiated Feb 20, 2019) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On February 20, 2019, the firm sent a "Urgent: Medical Device Recall/Field Safety Notice" via email to all consignees. The customer notification informed customers of the following: 1. As an immediate action, Luminex is requesting that customers discontinue use of and discard the products listedin the recall notice immediately or by the Discontinue Use By date. Contact Luminex Global Support Services to obtain replacement material. Material that is still within its Discontinue Use By date may be used at the customers discretion. 2. Complete the Acknowledgment and Receipt form. You must |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162772 | ARIES GBS Assay Luminex Corporation, Dec 23, 2016 |