Yeastone Broth recalled because it may report incorrect susceptibility results
Yeastone Broth is being recalled because the product may report incorrect antifungal susceptibility results during quality control, which could delay treatment or force a change of agent.
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: FDA Class II recall of a susceptibility test product that can report incorrect results and delay treatment, a risk of harm with no injuries reported.
Plain-English summary
Yeastone Broth, 11 mL, 10 per box, catalog YY3462, UDI-DI 848838018817, is being recalled. The action covers 2,819 units across lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851 and 311723.
The products may report incorrect antifungal susceptibility test (AST) results during quality control. According to the manufacturer, health consequences may include a delayed response or the need to change to another antifungal agent if the laboratory ignores the quality control test result. The FDA classified the action as Class II.
Distribution was worldwide, covering the United States nationwide and Canada, Vietnam, France, Argentina and Qatar among other markets. The product is used in clinical laboratories rather than sold to consumers.
Laboratories should identify affected stock using the UDI-DI and lot numbers above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Yeastone Broth, 11ML, 10/BOX YY3462
- Manufacturer
- Remel, Inc
- Affected units
- 2,819
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 (10)
- UDI-DI 848838018817 lots 321046
- 329835
- 330316
- 327069
- 330317
- 336325
- 338314
- 341161
- 303851
- 311723
Distribution
Distributed nationwide across the United States.
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