Device product
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
Z-0875-2021
Product summary
- Event
- Event 87146
- Status
- Terminated
- Classification
- Class II
- Quantity
- 276 units
- Official record key
device-enforcement:Z-0875-2021
Official wording
Reason: The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
Code information: Catalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407
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.
Derived failure modes
-
Labeling or packaging
label error
-
Manufacturing or process control
Quality Control (QC) card has a label error for the standard deviation