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U.S. Department of Health and Human Services

Class 2 Device Recall EDI

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  Class 2 Device Recall EDI see related information
Date Initiated by Firm August 18, 2020
Create Date September 30, 2020
Recall Status1 Open3, Classified
Recall Number Z-3051-2020
Recall Event ID 86335
510(K)Number K113046  K113501  
Product Classification Enzyme immunoassay, cocaine and cocaine metabolites - Product Code DIO
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
Code Information ALL Lots Within Expiry
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 2		 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 3600 units
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DIO and Original Applicant = AMEDITECH, INC.
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