Class 2 Device Recall CLIA Waived Immunoassay Enzyme

• Date Initiated by Firm: August 18, 2020
• Create Date: September 30, 2020
• Recall Status: Terminated on September 30, 2024
• Recall Number: Z-3032-2020
• Recall Event ID: 86335
• 510(K)Number: K122633
• Product Classification: Enzyme immunoassay, cannabinoids - Product Code LDJ
• Product: CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDDT-25 / CLIA Waived" Inc. Single Drug Dipstick Test BUP10, X07-CLIA-SDDT-25 / "CLIA Waived" Inc. Single Drug Dipstick Test BUP10, X07-CLIA-SDDT-13 /"CLIA Waived" Inc. Single Drug Dipstick Test OPI300, X07-CLIA-SDDT-25/"CLIA Waived" Inc. Single Drug Dipstick Test BUP10, X07-CLIA-14-RDTC-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", X07-CLIA-14-RDTC-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", X07-CLIA-12-RDTC-BUP-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G.", X07-CLIA-12-RDTC-BUP-A /"CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G.", X07-CLIA-14-RDTC-A /"CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", X07-CLIA-RDDT-70/ "CLIA Waived" Inc. Rapid Dip Drug Test COC300/OPI300/MET500/THC50/AMP1000/ PCP25/BZO300/BAR300/MTD300/OXY100/ MDMA500", X07-CLIA-RDDT-52/ "CLIA Waived" Inc. Rapid Dip Drug Test COC300/OPI300/MET500/THC50/AMP1000/ BZO300/BAR300/MTD300/BUPG10/OXY100", X07-CLIA-RDDT-70/ "CLIA Waived" Inc. Rapid Dip Drug Test COC300/OPI300/MET500/THC50/AMP1000/ PCP25/BZO300/BAR300/MTD300/OXY100/ MDMA500", X07-CLIA-RDDT-70/"CLIA Waived" Inc. Rapid Dip Drug Test COC300/OPI300/MET500/THC50/AMP1000/ PCP25/BZO300/BAR300/MTD300/OXY100/ MDMA500", X07-CLIA-12-RDTC-BUP-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G., X07-CLIA-12-RDTC-BUP-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G.", X07-CLIA-12-RDTC-BUP-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G., X07-CLIA-12-RDTC-BUP-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G.". X07-CLIA-12-RDTC-BUP-A "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G.", X07-CLIA-14-RDTC-A /"CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", X07-CLIA-14-RDTC-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", X07-CLIA-14-RDTC-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", CLIA-14-RDTC-A / "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG"
• Code Information: ALL Lots Within Expiry
• FEI Number: 3003789989
• Recalling Firm/ Manufacturer: Ameditech Inc; 9940 Mesa Rim Rd; San Diego CA 92121-2910
• For Additional Information Contact: Ms. Angela Occhionero; 858-619-4969
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 in Commerce: 120, 150
• Distribution: US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LDJ