Reported Jun 19, 2019 · Ongoing
xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple…
Luminex Molecular Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Luminex Molecular Diagnostics · 439 University Ave Suite 900 · Toronto, N/A · N/A
Is this the product you have?
- xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.
- Lot codes and dates
9 of 9 products
Products covered by this recall # Barcodes Product as published 1 Lot numbers IK032C-00061, exp. 11/30/2018 2 IK032C-00063, exp. 11/30/2018 3 IK032C-00064, exp. 12/31/2018 4 IK032C-00066, exp. 12/31/2018 5 IK032C-00067, exp. 11/30/2018 6 IK032C-00068, exp. 4/30/2019 7 IK032C-00069, exp. 7/31/2019 8 and IK032C-00071, exp. 12/31/2018 9 00840487100493UDI 00840487100493. - Amount recalled
- 965 kits
Where it was sold
Why it was recalled
Reports have been received of lower MS2 MFI values when using the panel.
This product could cause temporary or reversible health problems — stop using it.
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