FDA-Device2021-01-27Class II
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
Beckman Coulter Inc.
Hazard
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
Sold states
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS,KY, LA, MD, MI, MN, MO, NC, ND, NY, OH, OK, OR, PA, Puerto Rico, SD, TX, WA, and WV. The countries of Andorra, Belgium, Brazil, Bulgaria, Canada*, Croatia, France, Germany, Hong Kong, Italy, Jordan, Mexico, Paraguay, Poland, Portugal, Romania, Spain, and United Kingdom.
Affected count
276 units
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0875-2021Don't want to check this manually?
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