Exact FDA event identifier

Event 79245

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

Open FDA event record

Event summary

Timeline bucket: February 13, 2018
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

RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET¿ RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.

Z-1070-2018

Recall number: Z-1070-2018
Initiated: February 13, 2018
Classification: Class II
Status: Terminated
Recalling firm: Stanbio Laboratory, LP
Quantity: 686 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

All patient serum samples yield a weakly positive test result.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

All patient serum samples yield a weakly positive test result.

Code information

Lot 21675

Distribution pattern

Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad