Exact FDA event identifier

Event 73747

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

Event summary

Timeline bucket: March 31, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Hologic, 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

CF InPlex ASR Card; Catalog Number: 95-0501.

Z-1579-2016

Recall number: Z-1579-2016
Initiated: March 31, 2016
Classification: Class II
Status: Terminated
Recalling firm: Hologic, Inc
Quantity: 2580 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.

Code information

Lot Numbers: U34xx U35xx (xx denotes sublots)

Distribution pattern

Distributed in the states of OH, AL, IL, AZ, AR, NJ, TX, GA, CO, DE, NC, MI, FL, ME, CA, IN, OR, KS, KY, MO, WA, NY, OK, WV, CT, IA, LA, RI, MA, and PA, and in the country of Canada.

device · product 2 of 2

Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.

Z-1580-2016

Recall number: Z-1580-2016
Initiated: March 31, 2016
Classification: Class II
Status: Terminated
Recalling firm: Hologic, Inc
Quantity: 2580 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.

Code information

Lot Numbers: C33xx C34xx C35xx (xx denotes sublots)

Distribution pattern

Distributed in the states of OH, AL, IL, AZ, AR, NJ, TX, GA, CO, DE, NC, MI, FL, ME, CA, IN, OR, KS, KY, MO, WA, NY, OK, WV, CT, IA, LA, RI, MA, and PA, and in the country of Canada.