FDA Medical Device Recalls (openFDA)
Carolina Liquid Chemistries: CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
- Recall number
- Z-1253-2019
- Recalling firm
- Carolina Liquid Chemistries
- Product
- CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
- Status
- Terminated
- Initiated
- 2019-01-16
- Posted
- not on file
- Terminated
- 2021-02-02
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- The firm initiated the recall by email on 01/16/2019. The notice requested that the consignee discard the product.
- Quantity
- 20 kits
- Distribution
- NY. NH, ME, NC, TX, AR, SC, CT, IL, CA, NJ
- Lot, serial or model codes
- Lot 11687
- 510(k) numbers
- ["K032461"]
- PMA numbers
- not on file
- Product code
- DIC
- Firm FEI
- 3009880320
- Firm city
- Greensboro
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28