Z-0933-2022 Class II Terminated
FDA device recall Z-0933-2022 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Mar 8, 2022 and is designated Class II. Reason for recall: The product was stored incorrectly due to improper storage controls which may lead to delayed results. The recall status is terminated (terminated Feb 27, 2023). Affected quantity: 10 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 20, 2022
- Initiation Date
- Mar 8, 2022
- Termination Date
- Feb 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 boxes
Product Description
Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.
Reason for Recall
The product was stored incorrectly due to improper storage controls which may lead to delayed results.
Distribution Pattern
Distribution was made to AL, FL, NE OH, TX, WA, and WI. There was no foreign/military/government distribution.
Code Information
Lot numbers 172093, exp. 06/30/2023; 174703, exp. 08/31/2023; and 169141, exp. 04/30/2023.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0933-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026