CAROLINA — Class III medical device recall Z-1253-2019
Terminated recall by Carolina Liquid Chemistries, reported 2019-05-08, distributed in AR, CA, CT, IL, ME, NC, NH, NJ…. Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality cont
| Recall number | Z-1253-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carolina Liquid Chemistries, Greensboro, NC, United States |
| Recall initiated | 2019-01-16 |
| Classified | 2019-05-02 |
| Reported by FDA | 2019-05-08 |
| Terminated | 2021-02-02 |
| Distributed | AR, CA, CT, IL, ME, NC, NH, NJ, NY, SC, TX |
| Quantity | 20 kits |
| Reason classes | potency |
| Lot numbers | 11687 |
| Model numbers | T321 |
Product
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Reason for recall
Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not function toward the end of shelf life.
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-1253-2019. 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.