Z-0875-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2021
- Initiation Date
- December 30, 2020
- Termination Date
- September 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 276 units
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.
Distribution Pattern
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