CLASS II ONGOING Device recall · Reported 26 Feb 2025 · FDA Enforcement Report
Blood Agar MacCONKEY Agar Biplate recalled by Remel
Remel is recalling Blood Agar MacCONKEY Agar Biplate, distributed nationwide in the US. The recall was initiated on 13 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1200-2025
- FDA event ID
- 96312
- Recalling firm
- Remel, Lenexa, KS
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Feb 2025
- FDA classified
- 20 Feb 2025
- Reported
- 26 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Listeria
- Device type
- Test Kits & Diagnostics
Timeline
| 13 Feb 2025 | Recall initiated by company | |
| 20 Feb 2025 | Classified by FDA | +7 days |
| 26 Feb 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Listeria monocytogenes can grow at refrigerator temperatures. Infection is most dangerous for pregnant women, newborns, older adults and people with weakened immune systems. Symptoms can appear up to 70 days after eating contaminated food.
Product as listed by the FDA
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Where it was distributed
US Nationwide distribution.
Questions about this recall
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.
Which lots are affected?
UDI/DI 848838003691, Lot Number 213926, exp. 2025-02-24
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96312This product is part of a recall event; the main page for the event is Blood Agar Emb Agar Biplate recalled by Remel.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Blood Agar Emb Agar Biplate recalled by Remel | Remel | Listeria | Nationwide |
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