Abbott Peristaltic Head Tubing Recalled for Potential Leaking
Abbott Laboratories is recalling Peristaltic Head tubing for clinical chemistry systems due to a manufacturing issue that may cause the tubing to leak.
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 3/5 (High).
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Abbott Laboratories, Inc. is recalling 44 units of Tubing, Peristaltic Head Part Number 7-35009685-01. This product is used in clinical chemistry systems, specifically the ARCHITECT c4000, c8000, and c16000 models.
The recall was initiated because of a manufacturing issue associated with the tubing connector, which creates a possibility that the tubing may leak. The affected units have serial numbers 125589-1-2 and 125589-1-4.
The product was distributed worldwide to the United States, Canada, France, and Germany. Users of these clinical chemistry systems should contact Abbott Laboratories for instructions on how to proceed with the recall.
The recalled product
- Product
- Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
- Manufacturer
- Abbott Laboratories, Inc
- Hazard
- Affected units
- 44
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 (2)
- Serial numbers - 125589-1-2
- 125589-1-4
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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