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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95626

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

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Event summary

Timeline bucket
October 21, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Siemens Healthcare 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.

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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

Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect.

Z-0496-2025
Recall number
Z-0496-2025
Initiated
October 21, 2024
Classification
Class II
Status
Ongoing
Quantity
9729 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

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.

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Inspect official wording and provenance

Reason for recall

A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate.

Code information

Lot # UDI N1527024 (01)00630414596143(10)N1527024(17)20291002; N1526424 (01)00630414596143(10)N1526424(17)20291001; N1525924 (01)00630414596143(10)N1525924(17)20290924 ; N1525324 (01)00630414596143(10)N1525324(17)20290918 ; N1524224 (01)00630414596143(10)N1524224(17)20290911; N1523724 (01)00630414596143(10)N1523724(17)20290904; N1523024 (01)00630414596143(10)N1523024(17)20290827; N1521824 (01)00630414596143(10)N1521824(17)20290814; N1521424 (01)00630414596143(10)N1521424(17)20290808; N1519324 (01)00630414596143(10)N1519324(17)20290719; N1518924 (01)00630414596143(10)N1518924(17)20290716; N1518224 (01)00630414596143(10)N1518224(17)20290710; N1518324 (01)00630414596143(10)N1518324(17)20290710; N1516224 (01)00630414596143(10)N1516224(17)20290621; N1515624 (01)00630414596143(10)N1515624(17)20290612; N1514924 (01)00630414596143(10)N1514924(17)20290605; N1514124 (01)00630414596143(10)N1514124(17)20290530; N1513324 (01)00630414596143(10)N1513324(17)20290522; N1512824 (01)00630414596143(10)N1512824(17)20290515; N1512424 (01)00630414596143(10)N1512424(17)20290510; N1511224 (01)00630414596143(10)N1511224(17)20290506; N1510724 (01)00630414596143(10)N1510724(17)20290423; N1510124 (01)00630414596143(10)N1510124(17)20290419.

Distribution pattern

US Nationwide and Worldwide distribution: Foreign: Algeria Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile China Colombia Congo, Republic C¿te dIvoire Croatia Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Greece Hong Kong Hungary India Iran, Islamic Republic of Iraq Ireland Israel Italy Japan Jordan Kenya Kuwait Latvia Libya Malaysia Mexico Moldova, Rep. of Morocco Nepal Netherlands Norway Oman Pakistan Paraguay Peru Philippines Poland Portugal Qatar Republic Korea Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan, Province of China Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Great Britain Uruguay Vatikancity Vietnam

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