Recall Z-1058-2022 ยท QKO Reagent, Coronavirus Serological
PROTERIXBIO
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
| Date | Apr 17, 2022 |
| Status | Terminated |
| 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). |
| Root cause | Other |
| Action | On April 17, 2022, the firm notified affected physicians who had ordered tests and received results since September 2020 via email. Customers were informed that the prior test results may not have been accurate. In addition, customers were instructed to check their stock and destroy any remaining Dried Blood Spot Collection Kits (ProterixBio SARS-CoV-2 RBD Antibody Test sampling kits). Customers should note the number of kits destroyed in their response to the recalling firm. For questions and clarifications regarding this notification please call ProterixBio at 978-901-6649 or email support@ |
| Quantity | 640 kits |
| Distribution | Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.