Home / Recalls / Microgenics Corporation / Z-2884-2016

Z-2884-2016 Class II Terminated

Recalled by Microgenics Corporation — Fremont, CA

Recall Details

Product Type
Devices
Report Date
October 5, 2016
Initiation Date
July 25, 2016
Termination Date
November 21, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1708 kits

Product Description

DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.

Reason for Recall

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

Distribution Pattern

Worldwide Distribution: US (nationwide) to states of: AZ, CA, MO, TX, and PR and countries of: Canada, Germany, Hong Kong, Italy, Malaysia, and Taiwan.

Code Information

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

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