ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of I...
FDA Recall #Z-0875-2021 — Class II — December 30, 2020
Product Description
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
Reason for Recall
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
Recalling Firm
Beckman Coulter Inc. — Brea, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
276 units
Distribution
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.
Code Information
Catalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated