RecallRadar

FDA Device recall Z-2573-2018

Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540

On 2018-08-08 the FDA classified a Class III recall of Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540 by Diamedix, citing contains a gel-like contaminant that may affect product performance.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2573-2018
ClassificationClass III
Statusterminated
Initiated2018-01-05
Published2018-08-08
Last updated2026-09-13 11:54 UTC
CompanyDiamedix
DistributionAZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, WI

Product

Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540

Reason

Contains a gel-like contaminant that may affect product performance.

Identifiers

code_infoLot S0406 Exp. 05/31/2018

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2573-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.