Z-0933-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 20, 2022
- Initiation Date
- March 8, 2022
- Termination Date
- February 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.