Hardy Diagnostics: Medical Device Recall in 2016 - (Recall #: Z-1571-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.

Product Classification:

Class II

Date Initiated: March 21, 2016

Date Posted: May 4, 2016

Recall Number: Z-1571-2016

Event ID: 73688

Reason for Recall:

Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration.

Status: Terminated

Product Quantity: 3,530 (353 pk/10)

Code Information:

Lot H16054 and H15056.

Distribution Pattern:

U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated