Ameditech Recalls Thermo Fisher 6 Drug Cassettes Due to Reduced Reactivity
Ameditech is recalling Thermo Fisher 6 Drug Cassettes because they have shown reduced reactivity. The recall affects 220 units distributed in the US and Australia.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is reduced reactivity, which is a performance defect without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ameditech Inc is recalling Thermo Fisher 6 Drug Cassettes (Item No. MTPA-6MBAU, MTPA-8MBAU) because the devices have shown reduced reactivity. These are one-step immunoassays used for the qualitative detection of multiple drugs and drug metabolites in human urine, intended for professional and point-of-care use.
The recall involves 220 units with codes G150094 and G150136. The products were distributed nationwide in the United States and internationally to Australia.
Consumers and healthcare professionals should stop using the affected cassettes and contact Ameditech Inc for further instructions or a replacement.
The recalled product
- Product
- THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
- Manufacturer
- Ameditech Inc
- Affected units
- 220
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)
- G150094 G150136
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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.
See all 20 products in this recall →Related recalls
Same manufacturer · Ameditech Inc
See all →- ModerateAmeditech Noble 1 Step+ Cup Recalled for Inconsistent Performance
FDA (Devices) · 2020-10-07
- ModerateAmeditech iCup Dx14 Drug Screen Cup Recalled for Performance Failures
FDA (Devices) · 2020-10-07
- HighAmeditech Recalls ImmuTest Drugs of Abuse Cups for Performance Failures
FDA (Devices) · 2020-10-07
- ModerateAmeditech Fastect II Drug Screen Dipstick Tests Recalled for Performance Failures
FDA (Devices) · 2020-10-07
- ModerateAmeditech Recalls One Step + DOA Cup Due to Performance Failures
FDA (Devices) · 2020-10-07
Same hazard · reduced reactivity
See all →- ModerateSerology ToRCH positive control specimen recalled for decreased HSV reactivity
FDA (Devices) · 2024-01-10
- LowAmeditech DrugSmart Dip Benzodiazepine Test Recall for Reduced Reactivity
FDA (Devices) · 2015-12-30
- ModerateAmeditech ProScreen 6 Panel Dip Card Recall for Reduced Benzodiazepine Reactivity
FDA (Devices) · 2015-12-30
- ModerateAmeditech ProScreen 5 Panel Dip Card Recalled for Reduced Benzodiazepine Reactivity
FDA (Devices) · 2015-12-30
- ModerateAmeditech ProScreen 12 Drug Cup Recall for Reduced Benzodiazepine Reactivity
FDA (Devices) · 2015-12-30
Similar recalls
- LowAmeditech 6 Drug Cassette Recall for Reduced Benzodiazepine Reactivity
FDA (Devices) · 2015-12-30
- ModerateAmeditech Recalls Thermo Fisher 8 Drug Cassettes Due to Reduced Reactivity
FDA (Devices) · 2015-12-30
- ModerateAmeditech Recalls TDDA Drugs of Abuse Cups Due to Performance Failures
FDA (Devices) · 2020-10-07
- HighAmeditech Recalls ProScreen Drugs of Abuse Tests Due to Performance Failures
FDA (Devices) · 2020-10-07
- HighAmeditech Recalls ImmuTest Drugs of Abuse Cups for Performance Failures
FDA (Devices) · 2020-10-07
- ModerateAmeditech Recalls Consult Diagnostics Drugs Abuse Test Cups
FDA (Devices) · 2020-10-07