Z-2113-2014 Class II Terminated
FDA device recall Z-2113-2014 was initiated by Biogenex Laboratories, Inc. on July 1, 2014 and is designated Class II. Reason for recall: Product was distributed without 510(k) approval. The recall status is terminated (terminated July 24, 2014). Affected quantity: 4 kits.
Recall Details
- Product Type
- Devices
- Report Date
- July 30, 2014
- Initiation Date
- July 1, 2014
- Termination Date
- July 24, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 kits
Product Description
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Reason for Recall
Product was distributed without 510(k) approval.
Distribution Pattern
Brazil and Ecuador. No US distribution
Code Information
Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014.