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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77405

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

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Event summary

Timeline bucket
May 22, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sentinel CH SPA

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

MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2

Z-2867-2017
Recall number
Z-2867-2017
Initiated
May 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sentinel CH SPA
Quantity
2356 kits Worldwide; US 206 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.

Code information

Catalog Number 8L24-31: Lot Numbers: 60335Y600, 60382Y600 (Exp. Date 2018-02-28); Catalog Number 8L24-41: Lot Number: 60334Y600, (Exp. Date 2018-02-28)

Distribution pattern

Nationwide Distribution