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Hematology · 510(k) · 2013

UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

BECKMAN COULTER, INC.. Cleared by FDA on 22 March 2013 under submission K120771, product code GKZ (counter, differential cell). What FDA's record says, in FDA's words.

Device record · K120771

  1. Device. UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMDEVICE
  2. Company. BECKMAN COULTER, INC.COMPANY
  3. Decision. 22 March 2013, 510(k), substantially equivalent (abbreviated review); received 14 March 2012DECISION
  4. Panel. HematologyPANEL
  5. Product code. GKZ, Counter, Differential CellCODE
  6. Regulation. 21 CFR 864.5220, Class IIREG
  7. Source. FDA database entry · decision document (25 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, verbatim, from the decision document.

. See Intended Use above. UniCel DxH 800 COULTER Cellular Analysis System Update 5 1 0(k) submission Section 5: 5 10(k) Summary - Updated C) :UE U U c o e "r > j u .4 -U x zftr4f = 0 uU W m u OWU t .52 >1 U >u u :5 Z.6 F- 0U 00 r-z 0 00 0 0 00 000 X0 u00 0 -o~ ~~~ -e -0~- o- .. C . . . . . . . .. . . > C> C,) uu uu 0 U) m. CD C.C U oN z z-a g~- 4)C)U u u C )E 0 La 4Z) 4L 0 to -z: .2 tA .E o a 'M. 000 0000 o ) C, C, C) g 40 $ ) C 4- I- )~4 4) S E to u l.U) C: 0 E to A 0 "0 r0 to u0 .. 0 E) m to 0). o o o o ~ ~~~t a CQ. a > 0 .c cc E 0a ,C M ~C 0 = mC 4) 4) >) w ) 4)u w cc cccc c 4) c 0D C) C)C) C)~ E -r-z) ~ . 4)4) 4). toc Z: . t 0. t 0 ca to a, E a~ C11)s' ClEtoE bbE5 o o S ct. 00 C 4 -4 C '4 00 c~ E 00 0 to '4-' 0 C) 0 ,~ '0 0 -~ ~ E CAI 96 P La z a S.. t ~0 ZL o2j 0 HE-M 0. * I-~ C d 0 U 2Z. P. >) < >) 0 4)m C .c =y E5. g& 0 0 b< 0 <9F-- to - ~ 0 'n 0~' )~)V QV C)~ >. U z 0 C)< CL U E , 0. C ua E m~ 0 OU~ UU~ co=Ct -C LD -< co l<L 20 E m o 00 u~u 0 , , U u 2 0 CA E- o 4 E t> E0o.u 2 4o > 0 Et E N Q4- <~ 0 <N .4-, ~< .00 e ~ Si< ~ "0M vu)C1CO~ZC U *~jV~ .4)- 0Z 0< . &T'fle~<~0 C ~ cno 00 a~r a0 U&.~ W 1 J2 0 N Q .Q -<f 5.sl > ~ f -o~ ~ a~0bl IS E *5 E; co r I - . 4 0- -~ 0 4- < u cz.rC 025 7 3 0.= 0 ) O V) j .:j- 0 Z O L u< ) 0 >Oo~u 0- 0 U,0 0 jc ~ -C -< C< aa u V') C6 C <00 > CL CIOa ~ E -E S0 CCD C4- 0.q .0j 0 b 7 6 4t -u. 0 00. 4) m w V) H- ~i- 0- cn 4 o ~ )>~'A~ 0 < IM- ) u - '-'' u~on -~ ~e 8 ~I ccSE ~ > w0 4 Z 2 c >, ~ eq Eu u~4)~C r - Cll C) t 0C . […]

K120771, FDA decision document · source

What the statement says

Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.

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

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