Z-0606-2018 Class II Terminated
FDA device recall Z-0606-2018 was initiated by Gibson Laboratories LLC on January 20, 2017 and is designated Class II. Reason for recall: The firm information that the product was reporting false positive results The recall status is terminated (terminated February 20, 2018). Affected quantity: 10/1 mL vials.
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- January 20, 2017
- Termination Date
- February 20, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10/1 mL vials
Product Description
Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.
Reason for Recall
The firm information that the product was reporting false positive results
Distribution Pattern
Distributed to the states of AL, AZ & MS.
Code Information
Lot # 5072543 Exp Date 03/12/2021; UDI : 10634853000039.