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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82064

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

Open FDA event record

Event summary

Timeline bucket
January 10, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PerkinElmer Life and Analytical Sciences, Wallac, OY

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

3 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 3

DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.

Z-1237-2019
Recall number
Z-1237-2019
Initiated
January 10, 2019
Classification
Class II
Status
Ongoing
Quantity
31 kits (10 in US, 21 in ROW)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

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

hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

Code information

Kit Lot Numbers: 664891, 666471, 666604 Pack Lot Numbers: 1066489101, 1066647101,1066660401 UDI: (01)06438147009176(17)190430(10)664891 (01)06438147009176(17)190430(10)666471 (01)06438147009176(17)190430(10)666604

Distribution pattern

Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.

device · product 2 of 3

AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).

Z-1238-2019
Recall number
Z-1238-2019
Initiated
January 10, 2019
Classification
Class II
Status
Ongoing
Quantity
79 kits (none in US, all in ROW)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

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

hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

Code information

Kit Lot Numbers: 664670, 666553 Pack Lot Numbers: 1066467001, 1066467002, 1066655301 UDI: (01)06438147009336(17)190430(10)664670 (01)06438147009336(17)190430(10)666553

Distribution pattern

Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.

device · product 3 of 3

AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).

Z-1239-2019
Recall number
Z-1239-2019
Initiated
January 10, 2019
Classification
Class II
Status
Ongoing
Quantity
304 kits (United States)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

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

hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

Code information

Kit Lot Numbers: 664303 Pack Lot Numbers: 1066430301, 1066430302 UDI: (01)06438147009343(17)190430(10)664303

Distribution pattern

Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.