Ameditech Inc: 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

Recall number

Z-3051-2020

Recalling firm

Ameditech Inc

Product

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

Status

Terminated

Initiated

2020-08-18

Posted

not on file

Terminated

2024-09-30

Reason

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.

Root cause

Process control

Action

A Field Corrective Action Notice letter was sent to affected consignees. The Customer notifications commenced on 19-Aug-2020. The consignees are requested to return all non-expired product in their possession to the recalling firm. Method of Notification, 1st contact: Written field corrective action notification letters will be sent via certified mail with delivery tracking to each consignee along with a pre-paid return label to return any product remaining in stock. 2nd & 3rd contact: Telephone, follow up email, or written mail communication will be used as necessary.

Quantity

3600 units

Distribution

US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain

Lot, serial or model codes

ALL Lots Within Expiry

510(k) numbers

["K113046","K113501"]

PMA numbers

not on file

Product code

DIO

Firm FEI

3003789989

Firm city

San Diego

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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