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Beckman Coulter Inc. Recall 87146

Description: 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. Recall 87146 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0875-2021
Event ID87146
Event DescriptionACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
Product TypeDevices
DistributionWorldwide 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.
Quantity276 units
Recall ReasonThe Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
Device Classification20210127
Device Code InfoCatalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407
Center Classification Date20210115
Recall Initiation Date20201230
Recalling FirmBeckman Coulter Inc.
Initial Notification Letter
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