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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89829

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

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Event summary

Timeline bucket
March 16, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stanbio Laboratory, LP

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

Separation Technology Creamatocrit Plus, Catalog Number: 100-146

Z-0905-2022
Recall number
Z-0905-2022
Initiated
March 16, 2022
Classification
Class II
Status
Terminated
Recalling firm
Stanbio Laboratory, LP
Quantity
50

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)

Code information

Sold between 2019 and 2021

Distribution pattern

US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN