Exact FDA event identifier

Event 92609

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

Event summary

Timeline bucket: May 19, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Qiagen GmbH

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

QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223

Z-2245-2023

Recall number: Z-2245-2023
Initiated: May 19, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Qiagen GmbH
Quantity: 386 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated

Code information

GTIN 14053228038846 LOT Numbers: 175010704, 175011354 Exp. Date: 2023-10-06 and 2023-10-17

Distribution pattern

DC, AL, CA, FL, GA, ME, NC, NY, OR, TX Foreign: DE, AE, AT, BE, BG, CH, CL, CY, CZ, DE, DK, ES, FI, FR, GB, GR, GT, HK, HU, ID, IN, IT, JO, MC, MU, MY, NL, NA, PL, PT, RO, SE, SK, TH, TN, TW, UY, YT, ZA

device · product 2 of 2

QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214

Z-2246-2023

Recall number: Z-2246-2023
Initiated: May 19, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Qiagen GmbH
Quantity: 4155 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated

Code information

LOT Numbers: LOTs 172043034, 172043348, 172043349, 172043369, 172044712, 172048091, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669, 172046775, 172048381 Exp. Date: 2023-10-06 and 2023-10-17