Z-0825-2018Class II

ST AIA-PACK PROG II, Progesterone II Assay, Part Number: 025239

Name: Z-0825-2018 ST AIA-PACK PROG II, Progesterone II Assay, Part Number: 025239
Creator: Tosoh Bioscience Inc
Published: 2018-02-13
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2018-02-13 / Terminated / root cause: design

FDA source

Tosoh Bioscience Inc began a recall of ST AIA-PACK PROG II, Progesterone II Assay, Part Number: 025239 on 2018-02-13. FDA classified it as Class II and gives the reason as "Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of DHEA-S, a metabolite of the DHEA (dehydroepiandrosterone) supplement". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0825-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-13
Posted: 2018-03-01
Terminated: 2020-10-29
Recalling firm: Tosoh Bioscience Inc
Product: ST AIA-PACK PROG II, Progesterone II Assay, Part Number: 025239
Product code: JLS Radioimmunoassay, Progesterone
Reason for recall: Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of DHEA-S, a metabolite of the DHEA (dehydroepiandrosterone) supplement.
Root cause tag: design
FDA root cause: Device Design
Action: The assays identified in the above table must not be used to report results for patients who are taking DHEA supplements. " For patients that are taking DHEA supplements, an alternative testing method which is not expected to show cross reactivity to DHEA-S should be used such as Liquid Chromatography-Mass Spectroscopy (LCMS). " Please review the information in this Urgent Medical Device Recall with your Medical Director and/or Lab Director, as soon as possible. " Continue to use the Progesterone Assays for patients who are not receiving DHEA supplements or therapy. " Complete and return the attached Urgent Medical Device Recall Acknowledgement Form within 15-days. " Maintain this notification with your laboratory records and forward this information to others who may have received this product. " If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the products identified in the table above, contact Tosoh Technical Support 24 hours a day, seven days a week at 1(800) 248-6764 or email [email protected]. " Should you have any questions regarding this medical device recall, please feel free to contact Bernadette OConnell at 1(800) 248-6764, or by email at [email protected]. We will be available to answer any questions Monday - Friday, from 8:00 AM to 5:00 PM (PST).
Quantity in commerce: 5579
Distribution: Distributed in 39 states: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0825-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0825-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01
Z-0826-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

Product code JLS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)