Device recall: DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for…

Class II FDA enforcement event 74861. Recall start date: 25 Jul 2016. Status in the FDA record: Terminated. Termination date: 21 Nov 2016.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Microgenics Corporation started this device recall on 25 Jul 2016. The firm address in the FDA record is in Fremont, CA. FDA put the recall in Class II. FDA event 74861 has 1 product record. The first FDA enforcement report date is 5 Oct 2016. The record gives the status Terminated, with the termination date 21 Nov 2016.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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

Recalling firm

Microgenics Corporation, Fremont, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 74861: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2884-2016	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.	1708 kits	Class II	Terminated	5 Oct 2016

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2016: 1,232
Share of these events in Class II: 91%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 8

Other events of the firm

Other FDA enforcement events of Microgenics Corporation
Initiated	Product (first record)	Type	Class	Records
1 Oct 2025	Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OC	Device	Class II	1
20 Jan 2022	QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 Q	Device	Class II	1
15 Aug 2016	Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product	Device	Class II	1
20 Oct 2014	MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed co	Device	Class II	1
2 Dec 2013	MAS Omni Immune Controls	Device	Class III	2
13 May 2013	Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Mi	Device	Class II	1
20 Aug 2012	Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use a	Device	Class III	1

Microgenics Corporation: all 8 events

Official channels

FDA enforcement report Z-2884-2016The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 74861. https://recallregister.com/fda/ii/74861/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this 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.
What quantity of product is in FDA event 74861?: The FDA record gives this quantity: 1708 kits
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2016 have the same class?: 91% of the 1,232 device events that started in 2016 are in Class II.