MEDLINE INDUSTRIES, LP – Northfield Recall 89801
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.
MEDLINE INDUSTRIES, LP – Northfield Recall 89801 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0933-2022 |
| Event ID | 89801 |
| Event 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. |
| Product Type | Devices |
| Distribution | Distribution was made to AL, FL, NE OH, TX, WA, and WI. There was no foreign/military/government distribution. |
| Quantity | 10 boxes |
| Recall Reason | The product was stored incorrectly due to improper storage controls which may lead to delayed results. |
| Device Classification | 20220420 |
| Device Code Info | Lot numbers 172093, exp. 06/30/2023; 174703, exp. 08/31/2023; and 169141, exp. 04/30/2023. |
| Center Classification Date | 20220414 |
| Recall Initiation Date | 20220308 |
| Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Initial Notification | Letter |
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