Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
Reported: January 6, 2016 Initiated: November 23, 2015 #Z-0556-2016
Product Description
Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
Reason for Recall
FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
Details
- Recalling Firm
- Biomerieux Inc
- Units Affected
- 24 cartons
- Distribution
- US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.
- Location
- Hazelwood, MO
Frequently Asked Questions
What product was recalled? ▼
Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.. Recalled by Biomerieux Inc. Units affected: 24 cartons.
Why was this product recalled? ▼
FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 6, 2016. Severity: Moderate. Recall number: Z-0556-2016.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11