Pregnancy tests recalled over rodent activity in a distribution center
Gold Star Distribution is recalling pregnancy tests over potential exposure of rodents and rodent activity in its distribution center.
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: Scored 3 under the risk-of-harm criterion: the record cites rodent exposure and activity affecting distributed product, and no injuries are reported.
Plain-English summary
Pregnancy Test, 24ct, under UPC 048155920200, distributed by Gold Star Distribution Inc, is being recalled.
The reason given in the enforcement record is potential exposure of rodents and rodent activity in the distribution center.
The record's quantity field reads 'N/A'. UPC codes for the affected items are recorded in the enforcement record. The record gives distribution as US nationwide in the states of Minnesota. The FDA has classified the action as Class II.
Consumers who have this product should not use it and should follow the retailer's return instructions.
The recalled product
- Product
- PREGNANCY TEST 24CT
- Manufacturer
- GOLD STAR DISTRIBUTION INC
- Category
- Medical Device — Diagnostic test
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)
- UPC 048155920200
Distribution
Part of a larger recall action
This product is one of 5 recalled by GOLD STAR DISTRIBUTION 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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