Exact FDA event identifier

Event 82599

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

Open FDA event record

Event summary

Timeline bucket: March 15, 2019
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Cytocell Ltd.

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

Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.

Z-1202-2019

Recall number: Z-1202-2019
Initiated: March 15, 2019
Classification: Class III
Status: Terminated
Recalling firm: Cytocell Ltd.
Quantity: 19

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is an error in the chromomap included in the labeling for the product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is an error in the chromomap included in the labeling for the product.

Code information

Lot numbers: 056996 061156 062616 062808

Distribution pattern

The products were distributed to the following US states: IL, TN.