Beckman Coulter Inc. Recall 88261
Description: ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
Beckman Coulter Inc. Recall 88261 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2257-2021 |
| Event ID | 88261 |
| Event Description | ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737; |
| Product Type | Devices |
| Distribution | US Nationwide Distribution in the states of Alabama Alaska Arizona Arkansas California Connecticut Delaware Florida Georgia Idaho Illinois Indiana Iowa Kentucky Louisiana Maine Maryland Massachusetts Michigan Mississippi New Hampshire New Jersey New York North Carolina Ohio Oklahoma Oregon Pennsylvania Puerto Rico Tennessee Texas Virginia West Virginia, Wisconsin OUS: New Zealand, Libya |
| Quantity | 544 units |
| Recall Reason | SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . |
| Device Classification | 20210818 |
| Device Code Info | All Lots |
| Center Classification Date | 20210812 |
| Recall Initiation Date | 20210701 |
| Recalling Firm | Beckman Coulter Inc. |
| Initial Notification | Letter |
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