Hematology · 510(k) · 2018
Athelas One
Athelas Inc.. Cleared by FDA on 5 November 2018 under submission K181288, product code GKZ (counter, differential cell). What FDA's record says, in FDA's words.
Device record · K181288
- Device. Athelas OneDEVICE
- Company. Athelas Inc.COMPANY
- Decision. 5 November 2018, 510(k), substantially equivalent (traditional review); received 16 May 2018DECISION
- Panel. HematologyPANEL
- Product code. GKZ, Counter, Differential CellCODE
- Regulation. 21 CFR 864.5220, Class IIREG
- Source. FDA database entry · decision document (17 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement could not be read from a public decision document for this submission on the retrieval date (the document is absent, scanned without text, or filed under another number). FDA's database entry is the place to read it.
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 23,449 reports filed against devices carrying product code GKZ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
18 September 2026 · Malfunction · Alinity hq Analyzer · Abbott Laboratories · report 3016438761-2026-00518
17 September 2026 · Malfunction · Alinity hq Analyzer · Abbott Laboratories · report 3016438761-2026-00516
The customer observed falsely depressed Hemoglobin on the Alinity hq Processing Module for one female patient. The following results were provided:(b)(6) 2026, SID (b)(6), initial Hemoglobin results= 78 g/L, 76 g/L; repeat result on a recollected sample= 84 g/L; result from (b)(6) 2026= 84 g/L (reference range 120 to 160 g/L). There was no impact to patient management reported.
14 September 2026 · Malfunction · Alinity hq Analyzer · Abbott Laboratories · report 3016438761-2026-00504
The customer observed falsely decreased Hemoglobin (Hgb) results on a 52-Year-old male patient on an Alinity hq analyzer. Results were reported and were questioned by the medical provider. The following data was provided:SID (b)(6): Initial results 78.6 g/L(7.86 g/dL), repeat results 78.2 g/L(7.82 g/dL), Repeat results with different sample on Another Alinity hQ analyzer (b)(6) = 84.4 g/L(8.44 g/dL) and 83.9 g/L (8.39 g/dL). There was no impact to patient management reported.
9 September 2026 · Malfunction · Alinity hq Analyzer · Abbott Laboratories · report 3016438761-2026-00495
4 September 2026 · Malfunction · CELL-DYN Ruby · Abbott Laboratories · report 2919069-2026-00008
The customer observed falsely decreased hemoglobin (Hgb) results by the CELL DYN Ruby analyzer for a 82yrs old female patient. The results provided were:On (b)(6)2026 SID (b)(6) Hemoglobin: Initial=6.44 g/dL /repeated=6.31 g/dL.Redrawn and repeated SID (b)(6) =10.1 g/dL.On (b)(6)2026=9.4 g/dL.ON (b)(6)2026=10.2 g/dL.On (b)(6)2026=11.0 g/dL.ON (b)(6)2026=12.3 g/dL.On (b)(6)2026=10.7 g/dL.There was no reported impact to patient management.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
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