| Date Initiated by Firm | August 18, 2020 |
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| Create Date | September 30, 2020 |
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| Recall Status1 |
Terminated 3 on September 30, 2024 |
| Recall Number | Z-3042-2020 |
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| Recall Event ID |
86335 |
| 510(K)Number | K052115 K113046 |
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| Product Classification |
Alcohol control materials - Product Code DKC
|
| Product | ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description):
PSD-6MB/ "ProScreen" Drugs of Abuse Test
(MET1000/OPI2000)+AMP+BZO+COC+THC",
PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test
(COC/THC)+BZO+MTD+OPI300+OXY",
PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC),
PSD-10MOB "ProScreen" Drugs of Abuse Test
(COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD",
PSD-5M / "ProScreen" Drugs of Abuse Test
AMP/COC/MET1000/OPI2000/THC",
PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO |
|---|
| 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. |
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FDA Determined
Cause 2 | Process control |
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| 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. |
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| Quantity in Commerce | 51,075 units |
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| Distribution | US - Nationwide
OUS - Australia, France, Germany, New Zealand, Singapore and Spain |
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| 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.
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| 510(K) Database | 510(K)s with Product Code = DKC
510(K)s with Product Code = DKC
|
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