Exact FDA event identifier

Event 93125

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: April 24, 2023
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

2 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 2

Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only

Z-0215-2024

Recall number: Z-0215-2024
Initiated: April 24, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Cepheid
Quantity: 89,958 kits ( 10 test per kit)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.

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

pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.

Code information

UDI: (01)07332940006372/ Lots: 23718 23719 23720 10309 23201 23305 23308 23312 23314 23315 23401 23402 23403 23404 23405 23406 23407 23501 23504 23505 23506 23408 23410 23510 23411 23604 23605 23607 23608 23609 23610 23611 23612 23701 23702 23703 23705 23706 23707 23708 23709 23710 23711 23712 23714 23716 23717 23113 23316 23912 24112 23820 24704 24302 24307 24507 24508 24511 23822 23823 23824 24512 24513 24514 23825 24313 24515 24516 24517 24805

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emirates.

device · product 2 of 2

Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,

Z-0216-2024

Recall number: Z-0216-2024
Initiated: April 24, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Cepheid
Quantity: 1,413 kits ( 10 test per kit)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.

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

pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.

Code information

UDI: (01)07332940006297/ Lot: 23815

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emirates.