Abbott ARCHITECT c4000/c8000/c16000 Clinical Chemistry Systems May Leak
Abbott recalls ARCHITECT c4000, c8000, and c16000 clinical chemistry systems due to potential tubing leaks from a manufacturing issue with the peristaltic head tubing connector.
Lower-risk recall
The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.
Contact the company
What happened, in plain English
Abbott is recalling specific models of their ARCHITECT clinical chemistry systems because the peristaltic head tubing connector may leak due to a manufacturing defect. This could lead to improper sample handling or contamination in laboratory testing. Read more at govinfonow.com/recall/72926-abbott-architect-c4000-c8000-c16000-clinical-chemistry-systems-may-leak.
Source Summary by GovInfoNow · govinfonow.com/recall/72926-abbott-architect-c4000-c8000-c16000-clinical-chemistry-systems-may-leak · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0165-2018
Cite this page
“Abbott ARCHITECT c4000/c8000/c16000 Clinical Chemistry Systems May Leak.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72926-abbott-architect-c4000-c8000-c16000-clinical-chemistry-systems-may-leak. Based on FDA recall #Z-0165-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0165-2018%22&limit=1).
Why it’s dangerous
The peristaltic head tubing connector in these systems has a manufacturing defect that could cause leaks. This might lead to improper sample handling or contamination in laboratory testing procedures if the tubing leaks.
Who’s affected
Healthcare facilities using Abbott's ARCHITECT c4000, c8000, or c16000 clinical chemistry systems with the specified part numbers are most at risk. Laboratory staff and patients using these systems for testing may be affected.
How to tell if you have this one
Check if your system has the part numbers listed: c4000 (02P24), c8000 (01G06), or c16000 (03L77). These models are used in clinical chemistry testing and were sold with the specified part numbers.
- Brand
Abbott- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Completed- Distribution
Worldwide distribution to US, Canada, France, and Germany.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0165-2018 | ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.; c400073, c400103, c400498, c400600, c400890, c400934, c400935, c401018, c401055, c401056, c401182, c401505, c401520, c401686, c401887, c460196, c460200, c460943, c461550, c803669, c803753, c1600144, c1600249, c1600251, c1600641, c1600720, c1600819, c1600859, c1600976, c1601350, c1601351 | 34 units |
| Z-0166-2018 | Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.; Serial numbers - 125589-1-2, 125589-1-4 | 44 units |
What to do — step by step
Check Product Details
Identify your system model and part number to confirm if it is in the recall list.
How this recall unfolded
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0165-2018 (September 29, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0165-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.