FDAClass IIDecember 9, 2020

MassChrom Cortisol recall

MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their…

Why was MassChrom Cortisol recalled?

Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

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?

Order No. 0350, Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022)

Product
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their…
Recalling firm
Chromsystems Instruments & Chemicals GmbH
Quantity
850 vials
Distribution
US Nationwide distribution in the states of NC and NY.
Recall date
December 9, 2020
Classification
Class II
Status
Completed
Agency
FDA (device)
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