Abbott Alinity c Chemistry Analyzer Contains Unlabeled Latex Subcomponent
Abbott Laboratories is recalling 1,127 Alinity c Processing Module chemistry analyzers because unlabeled latex subcomponents are present. Users with latex allergies may experience serious allergic reactions upon contact.
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: FDA Class II recall for unlabeled latex allergen subcomponents on a widely distributed medical device used by healthcare workers. Latex is a common allergen with documented risk of serious allergic reactions in sensitized users. Source text does not report illnesses or injuries.
Plain-English summary
The Alinity c Processing Module is a fully automated chemistry analyzer used in clinical laboratories and medical facilities. Abbott Laboratories is recalling 1,127 systems of this device due to a labeling defect.
The recalled devices contain dry natural rubber (latex) subcomponents that are not labeled as containing latex. This creates a risk of allergic reaction for healthcare workers and other users with latex sensitivities who may come into contact with these components during device operation or maintenance.
The affected systems were distributed throughout the United States, including all 50 states, Puerto Rico, and in Brazil. Device identification is available through specific serial numbers provided in the FDA recall notice.
Users who have the affected Alinity c Processing Module should contact Abbott Laboratories for instructions regarding replacement or return of the device.
The recalled product
- Product
- Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinit
- Manufacturer
- Abbott Laboratories
- Hazard
- allergen-latex
- mislabeling
Distribution
Distributed in 47 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DE
- FL
- GA
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
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