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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97497

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

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Event summary

Timeline bucket
August 06, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Cepheid

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

Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique

Z-0414-2026
Recall number
Z-0414-2026
Initiated
August 06, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cepheid
Quantity
4,132 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.

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

As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.

Code information

Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Lot Numbers: 27815 27816 Batch Numbers: 1001424179 1001424181

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, and WY.