Reported Nov 12, 2014 · Terminated
Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
Access 2 Immunoassay SystemsCatalog No. 81600N386220Instructions for Use Part No. B14253A
- Product UsageThe 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
- Lot codes and dates
- Serial No. 504489 502713 503114 503824 504400 504373 501946 507570; 503285, 800337,509690, 509705 509724 509800 509771 509744 509746,
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509331, 509332 505348, 504964, 503973,138 of 138 codes
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509581,73 of 73 codes
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- Serial No. 504489 502713 503114 503824 504400 504373 501946 507570; 503285, 800337,
- Amount recalled
- 1,519 units total (403 units total)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the Access 2 Immunoassay systems because it may experience a "MFC Exception" error during normal operation of the Access 2 Immunoassay Systems.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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