# K955644: Synchron Systems Carbamazepine Test System

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Feb 16, 1996 after 66 days
- Product code: KLT (Enzyme Immunoassay, Carbamazepine)
- Device class: 2
- Regulation: 21 CFR 862.3645
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K971287: Synchron Systems Drug Calibration 3 Plus (1997), 0 descendants of its own

## Recalls of this device
- Aug 11, 2009 · Not classified · Z-1174-2012: The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator.
- Aug 11, 2009 · Not classified · Z-1173-2012: The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator.
- Feb 19, 2009 · Not classified · Z-2437-2010: The reagent produces false low test results. Beckman Coulter has confirmed low recovery of values at the low end of the therapeutic range (<1.5 ug/mL, <3.13 umol/L) with SYNCHRON Systems Gentamicin Re
- Jun 11, 2003 · Not classified · Z-0935-04: Product was found to produce higher recoveries by about 7-12% compared to other lots.

Source page: https://510kreport.com/device/K955644
Methodology: https://510kreport.com/methodology