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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87186

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

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Event summary

Timeline bucket
January 08, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cairn Diagnostics

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

13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.

Z-1128-2021
Recall number
Z-1128-2021
Initiated
January 08, 2021
Classification
Class II
Status
Terminated
Recalling firm
Cairn Diagnostics
Quantity
103 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates

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

Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates

Code information

Lot Codes: K021-021R, K021-022

Distribution pattern

US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.