# K030291: Coulter Act 5DIFF Autoloader (AL)

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter, Inc.
- Decided: Apr 17, 2003 after 79 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Beckman Coulter HmX with Autoloader: named in the summary without a submission number
- (no number) Abbott CELL-DYN 4000: named in the summary without a submission number

## Most influential descendants
- K032013: Coulter Act 5DIFF AL Hematology Analyzer (2003), 1 descendant of its own
- K042173: Coulter a T 5DIFF Cap Pierce (CP) (2004), 0 descendants of its own

## Recalls of this device
- Feb 23, 2011 · Not classified · Z-1979-2011: The recall was initiated because Beckman Coulter identified a problem with occasional unexpectedly high results for RBC, HCT, PLT and MPV without instrument generated messages, for the first run of a 
- Apr 20, 2004 · Not classified · Z-0987-04: Software anomaly causes sample results to be not credible, reported as '0' or left blank. The next sample will also be incorrectly reported for the same parameter.

## Indications for use
The COULTERB AcTTM5diff Autoloader (AL) hematology analyzer is a 26-parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed-vial Autoloader mode or a Manual (Stat) mode (open- or closed-vial).

Source page: https://510kreport.com/device/K030291
Methodology: https://510kreport.com/methodology