Pregnancy Test Kits Recalled Due to Improper Storage Conditions
Family Dollar Stores is recalling 329,044 CLEARBLUE pregnancy test kits that were stored outside labeled temperature requirements from June to October 2023 at stores in 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 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: Medical device in risk-of-harm category (pregnancy test) recalled for improper storage outside labeled temperature requirements. No reported illnesses or injuries, consistent with Score 3 rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Family Dollar Stores, LLC is recalling 329,044 units of CLEARBLUE SMART COUNTDOWN PREGNANCY TEST (SKU 900260).
The recalled products were stored outside their labeled temperature requirements between June 1, 2023 and October 4, 2023.
The affected products were distributed to Family Dollar stores in the following states: GA, AL, MS, FL, LA, AR, AZ, KS, TX, OK, CO, NM, NE, UT, NV, WY, ID, SD, ND, CA, MT, OR, WA.
Consumers who purchased these test kits should not use them and should obtain an alternative pregnancy test. For additional information, contact Family Dollar Stores or the U.S. Food and Drug Administration.
The recalled product
- Product
- CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260
- Manufacturer
- Family Dollar Stores, Llc.
- Category
- Medical Device — Pregnancy Test
- Hazard
- 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.
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