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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81550

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

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Event summary

Timeline bucket
November 01, 2018
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
R & D Systems, 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

Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.

Z-0691-2019
Recall number
Z-0691-2019
Initiated
November 01, 2018
Classification
Class III
Status
Terminated
Recalling firm
R & D Systems, Inc.
Quantity
198 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.

Code information

Catalog number DTFR1, Lot number P180851

Distribution pattern

US Nationwide and worldwide distribution to FL, LA, NE, MA. International distribution to Japan, Mexico, South Korea, United Kingdom.