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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95668

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, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Kreatech Biotechnology Bv

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

Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495

Z-0522-2025
Recall number
Z-0522-2025
Initiated
November 01, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Kreatech Biotechnology Bv
Quantity
23 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An absence of signal could also be observed as a result of the suboptimal hybridization of the larger DNA fragments. The user may interpret potential background as a false positive result and an absence of signal as a false negative result, if proper positive and negative controls are not included.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An absence of signal could also be observed as a result of the suboptimal hybridization of the larger DNA fragments. The user may interpret potential background as a false positive result and an absence of signal as a false negative result, if proper positive and negative controls are not included.

Code information

UDI-DI: (01)08718858480241 Lot Number: 00088454

Distribution pattern

US States: FL, NY

Field note

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