FDAClass IIAugust 5, 2020

regard Migrating Indicator recall

regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically…

Why was regard Migrating Indicator recalled?

The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Lot 719

Product
regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically…
Recalling firm
Resource Optimization & Innovation LLC
Quantity
66 cases of 12,000 units per case
Distribution
US Nationwide distribution including in the states of MO, NC, AR, OK.
Recall date
August 5, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls