Z-2884-2016Class II

DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is...

Name: Z-2884-2016 DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is...
Creator: Microgenics Corporation
Published: 2016-07-25
License: https://open.fda.gov/license/

Microgenics Corporation / initiated 2016-07-25 / Terminated

FDA source

Microgenics Corporation began a recall of DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of... on 2016-07-25. FDA classified it as Class II and gives the reason as "Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2884-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-25
Posted: 2016-09-23
Terminated: 2016-11-21
Recalling firm: Microgenics Corporation
Product: 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.
Product code: DKJ Colorimetry, Salicylate
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.
FDA root cause: Under Investigation by firm
Action: The firm, Thermo Fisher Scientific, sent an "URGENT MEDICAL DEVICE FIELD ACTION" letter dated July 25, 2016 by regular mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to determine if they are using or have inventory of any of the affected lots; discontinue use and destroy any remaining inventory of affected lots per local wastes ordinances; retain a copy of the letter for laboratory records; if you have forwarded kits of the affected lots, provide a copy of letter to them; and complete and return attached Medical Device Field Action Response Form within 5 days to Thermo Fisher Scientific Technical Service via fax at 1-888-527-8001 (USA toll free), 510-979-5420 (outside of USA) or email to [email protected]. If you have any questions contact Technical Services at 1-800-232-3342 (USA only) or 510-969-5000 (outside the USA) press option 2 then option 3.
Quantity in commerce: 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.
Product codes and lots: Lot Number Expiration Date 60704602 DEC 2016; 72035410 JUL 2017; 72208738 FEB 2018; 72409454 OCT 2018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2884-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2884-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-23

Product code DKJ

K961131Class IISalicylate AssayDiagnostic Reagents, Inc. / cleared 1996-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)