Exact Sciences Sample Mixer 2 Recalled for Door Damage Incidents
Exact Sciences is recalling 15 Sample Mixer 2 units in Wisconsin due to door damage incidents caused by the Sample Holder lid.
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: The recall is classified as FDA Class II, and the source text describes a mechanical defect (door damage) without reporting any injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Exact Sciences Corporation is recalling 15 units of the Exact Sciences Sample Mixer 2, a device intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests. The recall is limited to units distributed in Wisconsin.
The recall is being conducted to correct incidents of Sample Mixer door damage. This damage occurs when the Sample Holder opens during a run and the Sample Holder lid makes contact with the Sample Mixer door. The affected units are identified by specific Equipment ID and Serial Number combinations, including MIX-0051 through MIX-0066.
No injuries or illnesses have been reported in connection with this recall. Users should contact Exact Sciences Corporation for further instructions on correcting the affected units.
The recalled product
- Product
- Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests
- Manufacturer
- Exact Sciences Corporation
- Hazard
- Affected units
- 15
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 (15)
- Equipment ID / Serial Number: MIX-0051 / MX00002051
- MIX-0052 / MX00002032
- MIX-0053 / MX00002028
- MIX-0054 / MX00002052
- MIX-0055 / MX00002043
- MIX-0056 / MX00002040
- MIX-0057 / MX00002050
- MIX-0058 / MX00002036
- MIX-0059 / MX00002027
- MIX-0060 / MX00002015
- MIX-0061 / MX00002016
- MIX-0063 / MX00002039
- MIX-0064 / MX00002033
- MIX-0065 / MX00002053
- MIX-0066 / MX00002014
Distribution
Distributed in 1 state:
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