FDA Device recall Z-1571-2016
Hardy Diagnostics GBS Detect Cat no
- FDA Device
- Class II
- terminated
- Published 2016-05-04
On 2016-05-04 the FDA classified a Class II recall of Hardy Diagnostics GBS Detect Cat no by Hardy Diagnostics, citing 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 produ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1571-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-21 |
| Published | 2016-05-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hardy Diagnostics |
| Distribution | AL, CT, FL, IL, IN, MA, MI, NC, OH, SC, TX, VA, WI, WV |
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.
Reason
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.
Identifiers
| code_info | Lot H16054 and H15056. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1571-2016%22
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