Home › Shire Human Genetic Therapies, Inc. › Anti-Drug Antibody Biomarker Specimen Collection Kit: Gaucher and Hunter Patient
Anti-Drug Antibody Biomarker Specimen Collection Kit: Gaucher and Hunter Patient
Shire Human Genetic Therapies, Inc. · Model 1 · UDI-DI 05060147022339
PQD
Prescription
0
510(k) clearances
19
Adverse events
1
Recalls
53
Facilities
Description
The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is to aid healthcare providers (HCPs) in collecting specimens from patients receiving ELAPRASE® or VPRIV® commercial therapy for the treatment of Hunter syndrome and Gaucher.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-16 | LetsGetChecked Inc. | Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result, a number of users received sa |
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