FDA Medical devices recall ·
remel BLOOD AGAR MacCONKEY AGAR BIPLATE recall
- Recall number
- Z-1200-2025
- Date
- (initiated February 13, 2025)
- Company / brand
- Remel, Inc
12076 Santa Fe Trail Dr, Lenexa, KS, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 787 units
- Hazard tags
- Listeria Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Why was it recalled?
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 848838003691, Lot Number 213926, exp. 2025-02-24
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1200-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.