Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number Recalled by Ameditech Inc Due to Various immunoassay enzymes failed product performance, thereby the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ameditech Inc directly.
Affected Products
Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX Uncut Sheet-Card/ 187877, 160130/ EDI COC Uncut Sheet-Cup/ 188168, 160180/ EDI PCP Uncut Sheet-Cup/ 189027, 160140/ EDI THC Uncut Sheet Cup /189028, 160170/ EDI BZO Uncut Sheet-Cup/ 189081, 160120/ EDI MET1000 Uncut Sheet-Cup/ 189082, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189123, 160130/ EDI COC Uncut Sheet-Cup/ 189124, 160160/ EDI OPI2000 Uncut Sheet-Cup/ 189166, 160163/ EDI OPI (300) Uncut Sheet-Cup/ 189191, 160110/ EDI AMP Uncut Sheet-Cup/ 189371, 160140/ EDI THC Uncut Sheet Cup/ 189372, 160123/ EDI MET(300) Uncut Sheet-Cup/ 189425, 160170/ EDI BZO Uncut Sheet-Cup/ 189426, 100163/ EDI OPI (300) Uncut Sheet-Card/ 189456, 160170/ EDI BZO Uncut Sheet-Cup/ 189565, 160180/ EDI PCP Uncut Sheet-Cup/ 189601, 160125/ EDI MET(500) Uncut Sheet-Cup/ 189748, 160130/ EDI COC Uncut Sheet-Cup/ 189786, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189844, 160180/ EDI PCP Uncut Sheet-Cup/ 189937, 160172/ EDI BZO(200) Uncut Sheet-CUP/189956 Updated 09/03/2020: EDI Affected products -Catalog Numbers/ Lot Numbers 31105-3/ PI-01081 60503s-3ZC/ PH-10132 60600/ PH-11005
Quantity: 3600 units
Why Was This Recalled?
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ameditech Inc
Ameditech Inc has 109 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report