First Response 2 CT Recalled for Improper Temperature Storage
Family Dollar recalled 329,044 First Response 2 CT units sold between June and October 2023 due to storage outside labeled temperature requirements. The recall affects 22 states.
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: FDA Class II recall for improper storage conditions affecting product quality. The storage-related nature of this hazard constitutes a moderate-level concern without indication of direct physical harm.
Plain-English summary
Family Dollar Stores, Llc. is recalling 329,044 units of First Response 2 CT (SKU 902343) sold between June 1, 2023 and October 4, 2023. The products were stored outside their labeled temperature requirements.
These products were distributed to Family Dollar stores in the following states: Georgia, Alabama, Mississippi, Florida, Louisiana, Arkansas, Arizona, Kansas, Texas, Oklahoma, Colorado, New Mexico, Nebraska, Utah, Nevada, Wyoming, Idaho, South Dakota, North Dakota, California, Montana, Oregon, and Washington.
The FDA classified this as a Class II recall.
The recalled product
- Product
- FIRST RESPONSE 2 CT, SKU 902343
- Manufacturer
- Family Dollar Stores, Llc.
- Category
- Medical Device — Diagnostic Test
- Affected units
- 329,044
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 (3)
- All units sold at stores between June 1
- 2023 and October 4
- 2023.
Distribution
Part of a larger recall action
This product is one of 10 recalled by Family Dollar Stores, Llc. 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 10 products in this recall →Related recalls
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