FDA Device recall Z-1253-2019
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
- FDA Device
- Class III
- terminated
- Published 2019-05-08
On 2019-05-08 the FDA classified a Class III recall of CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 by Carolina Liquid Chemistries, citing 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 e….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1253-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-01-16 |
| Published | 2019-05-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Carolina Liquid Chemistries |
| Distribution | AR, CA, CT, IL, ME, NC, NH, NJ, NY, SC, TX |
Product
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Reason
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.
Identifiers
| code_info | Lot 11687 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1253-2019%22
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