Z-1571-2016Class II

Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of...

Name: Z-1571-2016 Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of...
Creator: Hardy Diagnostics
Published: 2016-03-21
License: https://open.fda.gov/license/

Hardy Diagnostics / initiated 2016-03-21 / Terminated

FDA source

Hardy Diagnostics began a recall of Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus on 2016-03-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1571-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-21
Posted: 2016-04-26
Terminated: 2016-10-25
Recalling firm: Hardy Diagnostics
Product: 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 code: JSJ Culture Media, Selective And Non-Differential
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.
FDA root cause: Under Investigation by firm
Action: On 03/21/2016 customers were notified by phone, and were sent a notification letter. Customers were instructed via phone call to discard remaining plates of the implicated lot, and to notify the firm of how many plates are left. The firm stated that they will be issuing replacements. The firm stated that they will be sending written notification as well. The firm requested full name and e-mail or fax number in order to follow-up with the written notification. The customer notification letter instructs customers to complete, sign, scan/e-mail or fax back enclosed form stating compliance with the action regarding the specific lot. The firm requests the form be returned to the attention of the Quality Assurance Department at [email protected], fax number 805-614-9274. If the lab is unable to be reached via telephone and would like replacements or credit contact Customer Service Department at 800-266-2222, option 1. Replacements will be sent out at no charge. Any questions contact Technical Services Department at 800-266-2222, option 2 or via e-mail at [email protected].
Quantity in commerce: 3,530 (353 pk/10)
Distribution: U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.
Product codes and lots: Lot H16054 and H15056.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1571-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1571-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-26

Product code JSJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)