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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65779

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

Open FDA event record

Event summary

Timeline bucket
July 08, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Becton Dickinson & Co.

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

PrepStain AG. For use in the screening and detection of cervical cancer.

Z-2110-2013
Recall number
Z-2110-2013
Initiated
July 08, 2013
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
890 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.

Code information

Catalog Numbers - 05CR00021, 05CR00021R, 05CR00022, 05CR00022R, 05CR00023, 05CR00023R

Distribution pattern

Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.

device · product 2 of 3

PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.

Z-2111-2013
Recall number
Z-2111-2013
Initiated
July 08, 2013
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
890 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.

Code information

Catalog Numbers - 799-13000-00 and 799-13000-00R

Distribution pattern

Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.

device · product 3 of 3

PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.

Z-2112-2013
Recall number
Z-2112-2013
Initiated
July 08, 2013
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
890 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.

Code information

Catalog Numbers - 799-14000-00 (490100) and 799-14000-00R (490407)

Distribution pattern

Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.