Exact FDA event identifier

Event 74452

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: June 07, 2016
Product types: Device
Classifications: Class III
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

1 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 1

Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.

Z-2282-2016

Recall number: Z-2282-2016
Initiated: June 07, 2016
Classification: Class III
Status: Terminated
Recalling firm: Tosoh Bioscience, Inc.
Quantity: 41 single sets of Progesterone 3 calibrators

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Instructions For Use had incorrect lot number and calibrator values

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Instructions For Use had incorrect lot number and calibrator values

Code information

Catalog Number 02534001 (One set of Calibrators US) Lot G13C303 (only those received/repackaged in the US)

Distribution pattern

US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.