Exact FDA event identifier

Event 93543

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

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Event summary

Timeline bucket: November 06, 2023
Product types: Device
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: Randox Laboratories 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

SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. Catalog Number: SR10349

Z-0624-2024

Recall number: Z-0624-2024
Initiated: November 06, 2023
Classification: Class III
Status: Ongoing
Recalling firm: Randox Laboratories Ltd.
Quantity: 1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.

Code information

GTIN: 05055273216424 Bath/Lot Number: 157SR

Distribution pattern

NY, WV