FDA Recalls ASTUTE Electronic Quality Control Device for Storage Condition Excursion
Biomerieux Inc. is recalling ASTUTE electronic quality control devices due to temperature and time storage excursion that may compromise product performance in laboratory settings.
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 device used in clinical laboratory settings to verify diagnostic equipment function. Performance degradation due to storage condition excursion could compromise quality assurance procedures, posing a risk of diagnostic error and potential patient harm, even though no adverse events have been reported.
Plain-English summary
Biomerieux Inc. is recalling the ASTUTE electronic quality control device (Catalog 400016) due to temperature and time storage condition excursion. Products stored outside specified temperature and time parameters cannot guarantee performance.
The recall affects 5 units distributed nationwide throughout the United States. The affected batch numbers are: 21EQC0163I, 21EQC0162I, 21EQC0160I, 21EQC0158I, and 21EQC0174I.
The ASTUTE device is an electronic quality control reagent used in clinical and diagnostic laboratories to verify the proper operation of laboratory equipment and testing systems. Devices with compromised performance may not reliably fulfill their intended quality assurance function.
The recalled product
- Product
- ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
- Manufacturer
- Biomerieux Inc
- Affected units
- 5
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)
- UDI/DI 03573026565541
- Batch Numbers: 21EQC0163I
- 21EQC0162I
- 21EQC0160I
- 21EQC0158I
- 21EQC0174I
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 94 recalled by Biomerieux Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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