Device product
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.
Z-0933-2022
Product summary
- Event
- Event 89801
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 boxes
- Official record key
device-enforcement:Z-0933-2022
Official wording
Reason: The product was stored incorrectly due to improper storage controls which may lead to delayed results.
Code information: Lot numbers 172093, exp. 06/30/2023; 174703, exp. 08/31/2023; and 169141, exp. 04/30/2023.
Distribution pattern: Distribution was made to AL, FL, NE OH, TX, WA, and WI. There was no foreign/military/government distribution.
Derived failure modes
-
Unknown
The product was stored incorrectly due to improper storage controls which may lead to delayed results.