Reported Apr 27, 2022 · Ongoing

ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012,…

DNA Genotek Inc.

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: DNA Genotek Inc. · 3000-500 Palladium Dr · Kanata · N/A

Is this the product you have?

  • ORAcollect Dx
  • Catalog Number/SKU
    • OCD-100
    • OCD-100A
  • Material numbers
    • OCD-100
    • OCD-100.008
    • OCD-100.012
    • OCD-100.014+ACP078
    • OCD-100.014+ACP078
    • OCD-100.032 and OCD-100A
    • OCD-100A.022
    • OCD-100A.023
    • OCD-100A.024
    • OCD-100A.025
Lot codes and dates

150 of 150 products

Products covered by this recall
Model / numberBarcodesProduct as published
XI51262759500030901006275950003091722091310XI513, Lot
XI51362759500030901006275950003091722091410XI514, Lot
XI51462759500030901006275950003091722091610XI519, Lot
XI51962759500030901006275950003091722091610XI520, Lot
XI52062759500030901006275950003091722091710XI521, Lot
XI52162759500030901006275950003091722091810XI522, Lot
XI52262759500030901006275950003091722093010XI534, Lot
XI53462759500030901006275950003091722102810XJ536, Lot
XJ53662759500030901006275950003091722102810XJ537, Lot
XJ53762759500030901006275950003091722111510XK518, Lot
XK51862759500030901006275950003091722111610XK519, Lot
XK51962759500030901006275950003091722120310XL503, Lot
XL50362759500030901006275950003091722120310XL506, Lot
XL50662759500030901006275950003091722120410XL510, Lot
XL51062759500030901006275950003091722120510XL511, Lot
XL51162759500030901006275950003091722120610XL512, Lot
XL51262759500030901006275950003091722121410XL521, Lot
XL52162759500030901006275950003091722121510XL522, Lot
XL52262759500030901006275950003091722123110XL535, Lot
XL53562759500030901006275950003091723010410YA501, Lot
Amount recalled
2,375,514 (US: 2,148,222 OUS: 227,292)

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Evaporation of stabilizing liquid reducing shelf life.

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

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.