FDAClass IIOctober 5, 2016

DRI Salicylate Serum Tox Assay recall

DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of…

Why was DRI Salicylate Serum Tox Assay recalled?

Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.

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 Number Expiration Date 60704602 DEC 2016; 72035410 JUL 2017; 72208738 FEB 2018; 72409454 OCT 2018.

Product
DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of…
Recalling firm
Microgenics Corporation
Quantity
1708 kits
Distribution
Worldwide Distribution: US (nationwide) to states of: AZ, CA, MO, TX, and PR and countries of: Canada, Germany, Hong Kong, Italy, Malaysia, and Taiwan.
Recall date
October 5, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls