Culture media recalled over contamination that may darken the broth
Remel is recalling cation-adjusted Mueller Hinton broth and Brucella broth because the products may contain contamination, which may result in a darker or brown media color.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record states only a visible colour change from contamination, without describing a testing consequence or reported harm.
Plain-English summary
Two Remel culture media products are being recalled: CAMHB with lysed horse blood, manual, 11 mL, 10 per box (YCP112-10), and Brucella Broth, 11 mL, 10 per box (YT3450).
The products may contain contamination, which may result in a darker or brown media colour.
The recall covers 1,000 units in the United States and 280 elsewhere. The CAMHB product carries UDI-DI 848838018831 across lots 305529, 311228, 316019 and 320993; the Brucella broth carries UDI-DI 848838091353, lot 317287. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record describes the colour change without stating a further consequence, and reports no injuries. Laboratories holding affected lots should follow Remel's instructions.
The recalled product
- Product
- 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
- Manufacturer
- Remel, Inc
- Category
- Medical Device — Culture media
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 (6)
- 1. UDI-DI 848838018831
- lots 305529
- 311228
- 316019
- 320993 2. UDI-DI 848838091353
- lot 317287
Distribution
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