Ameditech Recalls CLIA Waived Rapid Drug Tests for Performance Failures
Ameditech Inc is recalling various CLIA Waived Rapid Drug Tests because immunoassay enzymes failed performance standards, preventing consistent detection of compounds.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical diagnostic device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Ameditech Inc is voluntarily recalling various CLIA Waived Rapid Drug Tests, including Single Drug Dipstick Tests and Rapid Drug Test Cups. The affected products include multiple item numbers such as X07-CLIA-SDDT-25, X07-CLIA-14-RDTC-A, and X07-CLIA-RDDT-70, with quantities of 120 and 150 units. The recall covers all lots within their expiry dates.
The recall was initiated because various immunoassay enzymes in the products failed to meet product performance standards. As a result, the tests do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. This defect may lead to inaccurate test results.
The affected products were distributed nationwide in the United States and in Australia, France, Germany, New Zealand, Singapore, and Spain. Users of these medical devices should stop using the recalled products and contact Ameditech Inc for further instructions or a replacement.
The recalled product
- 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…
- Manufacturer
- Ameditech Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ALL Lots Within Expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 23 recalled by Ameditech Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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