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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93238

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

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Event summary

Timeline bucket
September 12, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Ortho-Clinical Diagnostics, INc.

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

VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)

Z-0236-2024
Recall number
Z-0236-2024
Initiated
September 12, 2023
Classification
Class II
Status
Ongoing
Quantity
342 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could result in a missed or delayed diagnosis of acute pancreatitis and may lead to diagnostic confusion in the setting of acute abdominal symptoms. Falsely elevated levels would not result in patient harm but may cause diagnostic confusion and a delay in accurate diagnosis of a patient with abdominal pain.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could result in a missed or delayed diagnosis of acute pancreatitis and may lead to diagnostic confusion in the setting of acute abdominal symptoms. Falsely elevated levels would not result in patient harm but may cause diagnostic confusion and a delay in accurate diagnosis of a patient with abdominal pain.

Code information

Product Code 1668409: UDI-DI: 10758750009510, Affected Lots: 5905-3348-1557; Product Code 8297749: UDI-DI: 10758750004683, Affected Lots: 5905-3348-2899

Distribution pattern

US States: CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT. Canada, France, India, Japan, South Korea