Recall archive / FDA device enforcement
Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 245... — FDA record Z-0933-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 8, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- The product was stored incorrectly due to improper storage controls which may lead to delayed results.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 10 boxes
- Agency-reported status
- Terminated
- Source record identifier
- Z-0933-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot numbers 172093, exp. 06/30/2023; 174703, exp. 08/31/2023; and 169141, exp. 04/30/2023. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution was made to AL, FL, NE OH, TX, WA, and WI. There was no foreign/military/government distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 20, 2022
- Recall initiation date
- Mar 8, 2022
- Center classification date
- Apr 14, 2022
- Termination date
- Feb 27, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.