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U.S. Department of Health and Human Services

Class 2 Device Recall Oratect

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 Class 2 Device Recall Oratectsee related information
Date Initiated by FirmAugust 18, 2020
Create DateSeptember 30, 2020
Recall Status1 Terminated 3 on September 30, 2024
Recall NumberZ-3041-2020
Recall Event ID 86335
Product Classification Enzyme immunoassay, cannabinoids - Product Code LDJ
ProductOratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect III Oral Fluid Drug Screen Device MET25+THC40+COC20+AMP25+OPI10+BZO5 "
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 ContactMs. Angela Occhionero
858-619-4969
Manufacturer Reason
for Recall		XXX
FDA Determined
Cause 2		Process control
ActionA 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 Commerce1,325 units
DistributionUS - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
Total Product Life CycleTPLC 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.
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