FDAClass IIJanuary 11, 2023

Astute Reagent Astute Electronic Quality Ctrl Device US recall

ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016

Why was Astute Reagent Astute Electronic Quality Ctrl Device US recalled?

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 03573026565541, Batch Numbers: 21EQC0163I, 21EQC0162I, 21EQC0160I, 21EQC0158I, 21EQC0174I

Product
ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
Recalling firm
Biomerieux Inc
Quantity
5 units
Distribution
US Nationwide distribution.
Recall date
January 11, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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