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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0875-2021 |
| Event ID | 87146 |
| Event Description | ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only. |
| Product Type | Devices |
| 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. |
| Quantity | 276 units |
| Recall 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. |
| Device Classification | 20210127 |
| Device Code Info | Catalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407 |
| Center Classification Date | 20210115 |
| Recall Initiation Date | 20201230 |
| Recalling Firm | Beckman Coulter Inc. |
| Initial Notification | Letter |
| Similar To |