PROTERIXBIO Recall 90107
Description: ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
PROTERIXBIO Recall 90107 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1058-2022 |
| Event ID | 90107 |
| Event Description | ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number |
| Product Type | Devices |
| Distribution | Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA |
| Quantity | 640 kits |
| Recall Reason | FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives). |
| Device Classification | 20220518 |
| Device Code Info | Lots were not coded. All product will be recalled. |
| Center Classification Date | 20220511 |
| Recall Initiation Date | 20220417 |
| Recalling Firm | PROTERIXBIO |
| Initial Notification | |
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