Beckman Coulter Inc. Recall 87738
Description: Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
Beckman Coulter Inc. Recall 87738 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1670-2021 |
| Event ID | 87738 |
| Event Description | Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Alabama, 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 and the country of New Zealand. |
| Quantity | 1,034 units |
| Recall Reason | specimens collected in transport media may result is false negative results when stored in certain conditions. |
| Device Classification | 20210602 |
| Device Code Info | All Lots |
| Center Classification Date | 20210521 |
| Recall Initiation Date | 20210414 |
| Recalling Firm | Beckman Coulter Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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