Exact FDA event identifier

Event 79176

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: February 13, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Tosoh Bioscience Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-0825-2018

Recall number: Z-0825-2018
Initiated: February 13, 2018
Classification: Class II
Status: Terminated
Recalling firm: Tosoh Bioscience Inc
Quantity: 5579

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All lots

Distribution pattern

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.

device · product 2 of 2

ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240

Z-0826-2018

Recall number: Z-0826-2018
Initiated: February 13, 2018
Classification: Class II
Status: Terminated
Recalling firm: Tosoh Bioscience Inc
Quantity: 3322

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

All lots

Distribution pattern

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.