Beckman Coulter Recalls Access 2 Immunoassay Systems Due to Software Error
Beckman Coulter is recalling Access 2 Immunoassay Systems because the Small Form Factor Console PC may experience an 'MFC Exception' error during normal operation.
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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The source text does not report any specific injuries, illnesses, or deaths, and the hazard is a software error ('MFC Exception') rather than a direct physical or biological hazard.
Plain-English summary
Beckman Coulter Inc. is recalling the Access 2 Immunoassay Systems, including Catalog Nos. 81600N and 386220, and Instructions for Use Part No. B14253A. The recall involves the Small Form Factor Console PC (SFF PC) (B23083) used with these systems.
The recall is being conducted because the SFF PC may experience an 'MFC Exception' error during the normal operation of the Access 2 Immunoassay Systems. The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
A total of 1,519 units were distributed worldwide, including in the United States and numerous other countries. The source text does not specify the number of reported illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
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)
- Serial No. 504489 502713 503114 503824 504400 504373 501946 507570
- 503285
- 800337
- 509705 509724 509800 509771 509744 509746
- 508910
- 508912
- 508907 509373
- 509304 506566 508920 505811 508914
- 508917 509625 502796 508933
- 508934 509291 509634
- 509635 509530
- 509588 509787
- 509788
- 509783 509433
- 509437
- 509662
- 509663
- 509660
- 509659
- 509658 509715 509657 508916
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter 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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