Abbott Alinity m System camera firmware installation issue
Abbott Molecular is recalling 74 Alinity m Systems due to an issue with the installation of updated camera firmware. Affected devices were distributed in the United States and internationally.
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: This is an FDA Class II recall of 74 medical devices due to a camera firmware installation issue. No illnesses or injuries have been reported. Medical devices with potential for harm to patients, in the absence of reported illness or injury, receive High severity classification.
Plain-English summary
Abbott Molecular, Inc. is recalling 74 Alinity m Systems (Part No. 08N53-002) due to an issue with the installation of updated camera firmware on the system. The recalled devices are identified by specific serial numbers.
The affected devices were distributed in the United States, including California, Georgia, Illinois, New York, Texas, and other states, as well as internationally to multiple countries including Canada, Australia, and the United Kingdom.
No illnesses or injuries have been reported related to this issue. Users of affected devices should contact Abbott Molecular for guidance on device repair or replacement instructions.
The recalled product
- Product
- Alinity m System, Part No. 08N53-002
- Manufacturer
- Abbott Molecular, Inc.
- Category
- Medical Device
- Affected units
- 74
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)
- Alinity m System
- Model 08N53-002 74 impacted serial numbers: 00048
- 00076
- 00080
- 00091
- 00105
- 00111
- 00154
- 00155
- 00165
- 00189
- 00191
- 00207
- 00231
- 00232
- 00233
- 00239
- 00252
- 00254
- 00267
Distribution
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