Abbott Clinical Chemistry Systems Recalled for Tubing Leak Risk
Abbott is recalling 34 ARCHITECT c4000, c8000, and c16000 clinical chemistry systems because a manufacturing issue with the peristaltic head tubing may cause leaks.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, aligning with the criteria for a moderate severity score.
Plain-English summary
Abbott Laboratories, Inc. is recalling 34 units of ARCHITECT c4000, c8000, and c16000 clinical chemistry systems. The recall is due to a manufacturing issue associated with the tubing connector on the peristaltic head tubing, which creates a possibility of leaks.
The affected systems were distributed worldwide to the United States, Canada, France, and Germany. Specific unit codes are listed in the recall documentation.
Healthcare facilities should contact Abbott Laboratories for instructions on how to address the tubing issue.
The recalled product
- Product
- ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
- Manufacturer
- Abbott Laboratories, Inc
- Hazard
- Affected units
- 34
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 (20)
- c400073
- c400103
- c400498
- c400600
- c400890
- c400934
- c400935
- c401018
- c401055
- c401056
- c401182
- c401505
- c401520
- c401686
- c401887
- c460196
- c460200
- c460943
- c461550
- c803669
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Abbott Laboratories, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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