Carolina Liquid Chemistries Recalls Ethyl Alcohol Assay Kits
Carolina Liquid Chemistries is recalling 20 Ethyl Alcohol Assay Kits because supplier testing showed the absorbance rate did not meet internal quality control specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The defect is a functional failure (absorbance rate) rather than a direct safety hazard like contamination or injury.
Plain-English summary
Carolina Liquid Chemistries is recalling 20 units of the Ethyl Alcohol Assay Kit (Reference ST321), Lot 11687. The recall was initiated after supplier testing revealed that the absorbance rate of the assay did not meet the manufacturer's internal quality control specifications.
The defective kits are expected to fail to function properly toward the end of their shelf life. The affected products were distributed in New York, New Hampshire, Maine, North Carolina, Texas, Arkansas, South Carolina, Connecticut, Illinois, California, and New Jersey.
Consumers and healthcare facilities should stop using the affected kits and contact Carolina Liquid Chemistries for instructions on how to return the product.
The recalled product
- Product
- CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
- Manufacturer
- Carolina Liquid Chemistries
- Hazard
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 11687
Distribution
Part of a larger recall action
This product is one of 2 recalled by Carolina Liquid Chemistries under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Carolina Liquid Chemistries
See all →- LowCarolina Liquid Chemistries Recalls 14 Etha RGT. Kits for Quality Issues
FDA (Devices) · 2019-05-08
Same hazard · quality control failure
See all →- High5-PLASMA Bivalirudin AMR Verification Kit Recalled Due to Stability Issues
FDA (Devices) · 2026-08-12
- HighEXENT Analyser marked plates as passed without performing quality control
FDA (Devices) · 2026-06-17
- HighPreeclampsia growth factor assay recalled over out-of-range quality control values
FDA (Devices) · 2026-04-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- ModerateHeparin control material recalled after quality control results fell below acceptance range
FDA (Devices) · 2025-08-20