PlainRecalls
FDA Devices Moderate Class II Terminated

Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.

Reported: August 5, 2015 Initiated: June 26, 2015 #Z-2275-2015

Product Description

Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.

Reason for Recall

Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.

Details

Recalling Firm
Hardy Diagnostics
Units Affected
650 (65 pk/10)
Distribution
U.S. Nationwide Distribution and the country of: Canada
Location
Santa Maria, CA

Frequently Asked Questions

What product was recalled?
Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.. Recalled by Hardy Diagnostics. Units affected: 650 (65 pk/10).
Why was this product recalled?
Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 5, 2015. Severity: Moderate. Recall number: Z-2275-2015.