FDA Enforcement
Class III
Terminated
Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.
Recall: Z-2265-2016
·
Reported August 3, 2016
Enforcement
- Recall Number
- Z-2265-2016
- Event ID
- 74505
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Alere San Diego, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 3, 2016
- Initiation Date
- June 22, 2016
- Classification Date
- July 22, 2016
- Termination Date
- January 29, 2018
- Address
- 9975 Summers Ridge Rd, N/A, San Diego, CA, 92121-2997, United States
Description
Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.
Reason
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Code Info
all lots are affected
Distribution
US
Quantity
N/A