Hardy Diagnostics GBS Detect Cat no — Class II medical device recall Z-1571-2016
Terminated recall by Hardy Diagnostics, reported 2016-05-04, distributed in AL, CT, FL, IL, IN, MA, MI, NC…. Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the t
| Recall number | Z-1571-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hardy Diagnostics, Santa Maria, CA, United States |
| Recall initiated | 2016-03-21 |
| Classified | 2016-04-26 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2016-10-25 |
| Distributed | AL, CT, FL, IL, IN, MA, MI, NC, OH, SC, TX, VA, WI, WV |
| Lot numbers | H15056, H16054 |
| Model numbers | A300 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1571-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.