Abbott ARCHITECT c8000 System Recalled for Tubing Leak Risk
Abbott Laboratories is recalling five ARCHITECT c8000 systems because the tubing may not meet specifications and could leak.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential leak from non-specification tubing, which poses a risk of harm to the diagnostic process or equipment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Abbott Laboratories is recalling five units of the ARCHITECT c8000 System, List Number 01G06-98. The recall is due to tubing that does not meet specifications and has the potential to leak. The affected serial numbers are C802239, C802312, C802260, C802447, and C801911.
The ARCHITECT c8000 System is an in vitro diagnostic device intended for automated chemistry tests using photometry and potentiometric technology. The recall covers units distributed nationwide in California, Alabama, New York, and Wisconsin.
Healthcare facilities and users should stop using the affected units and contact Abbott Laboratories for instructions on replacement or repair. This recall is classified as Class II by the FDA.
The recalled product
- Product
- ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.
- Manufacturer
- Abbott Laboratories
- Hazard
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Serial Numbers: C802239
- C802312
- C802260
- C802447
- C801911
Distribution
Related recalls
Same manufacturer · Abbott Laboratories
See all →- HighChemistry analyzer control modules recalled over software that may give erroneous results
FDA (Devices) · 2025-12-24
- HighHematology analyzers recalled because saturation flags may not be applied
FDA (Devices) · 2025-11-19
- HighCELL-DYN Ruby hematology analyzer system expiration date validation
FDA (Devices) · 2025-04-30
- HighCELL-DYN Ruby Hematology Analyzer Expiration Date Software Defect
FDA (Devices) · 2025-04-30
- HighCELL-DYN Ruby hematology analyzer expiration date software defect
FDA (Devices) · 2025-04-30
Same hazard · leak
See all →- HighAVID Medical Recalls Halyard LAVH PACK Due to Sterilization Error
FDA (Devices) · 2026-08-26
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- HighAnti-siphon smallbore extension sets recalled over port weld separation risk
FDA (Devices) · 2025-11-05