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Recall Observatory FDA recall evidence

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

December 30, 2020

Class II

Product summary

Firm
Beckman Coulter Inc.
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

    reason.labeling_packaging · v1.0.0

    label error
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Quality Control (QC) card has a label error for the standard deviation