Hardy Diagnostics Recalls Strep B Carrot Broth Due to Incorrect Expiration Date
Hardy Diagnostics is recalling Strep B Carrot Broth One-Step units because the outer box displays an incorrect expiration date of 2021-11-10 instead of 2020-11-10.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a documentation/labeling error.
Plain-English summary
Hardy Diagnostics is recalling 8,620 units of Strep B Carrot Broth One-Step, Reference Z40, UDI 00819398026499, Lot # 465086. The recall is due to a labeling error on the outer box, which lists an expiration date of 2021-11-10 instead of the correct date of 2020-11-10.
The affected products were distributed in the United States, including Virginia, Arkansas, Wisconsin, Idaho, New York, Alabama, California, Montana, Texas, Minnesota, New Hampshire, Washington, North Carolina, Arizona, Alaska, Missouri, Florida, Michigan, Wyoming, Colorado, Puerto Rico, and Guam.
This is an FDA Class III recall, indicating that use of the product is not likely to cause adverse health consequences. Users should check the expiration date on the outer box of their Strep B Carrot Broth One-Step units and contact Hardy Diagnostics for further instructions if they possess the affected lot.
The recalled product
- Product
- Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
- Manufacturer
- Hardy Diagnostics
- Hazard
- Affected units
- 8,620
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)
- Lot # 465086
Distribution
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