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-100OCD-100A
- Material numbers
OCD-100OCD-100.008OCD-100.012OCD-100.014+ACP078OCD-100.014+ACP078OCD-100.032 and OCD-100AOCD-100A.022OCD-100A.023OCD-100A.024OCD-100A.025
- Lot codes and dates
150 of 150 products
Products covered by this recall Model / number Barcodes Product 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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