AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x…

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• AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD
• REF
  • AL-1002
  • kit contents
  • Ab PLATE 1 X ! Plate
  • IgM Sample DIL 1 x 100 mL
  • ENZ CONJ CONC 1 x 1.5 mL
  • Calibrators A-C 3 x 1.2 mL
  • CONJ DIL 1 X 12 mL
  • Stop SOLN 1 X 12 mL
  • TMB SOLN 1 X 12 mL
  • WASH CONC A 1 X 60 mL
  • (01)00853592008219 -
• Product Usageintended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider

Lot codes and dates

• Lot #/Expiration
• Date
  • 040720/2021-10-06
  • 041620/2021-10-15
  • 041720/2021-10-18
  • 042420/2021-10-15
  • 042720-A/2021-10-26

Amount recalled

327 kits (93 test per kit)

Where it was sold

• Nationwide
• TX
• MO
• OK
• MD
• FL
• NY
• OR
• GA
• NC

Why it was recalled

Labeling update; To reduce the risk of false positive/false negative results the IFU for the adaptive immune response to SRS-CoV-2 testing is being updated to remove Plasma as a "sample type" and to update the "limitation" section to include potential cross-reactivity with non-SARS-CoV2 strains.

This product could cause temporary or reversible health problems — stop using it.