Medline Industries Inc Recall 87184
Description: S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only.
Medline Industries Inc Recall 87184 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1135-2021 |
| Event ID | 87184 |
| Event Description | S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of MS, OH, IL. |
| Quantity | 46 units |
| Recall Reason | Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment. |
| Device Classification | 20210303 |
| Device Code Info | Model Number: S-O303000; Batch Numbers: 154950, 154590, 158668, 159370, 192532, 192891, 19365, 200831; Lot Number and/or Serial Number: 154950, 154590, 158668, 159370, 192532, 192891, 19365, 200831. |
| Center Classification Date | 20210219 |
| Recall Initiation Date | 20210115 |
| Recalling Firm | Medline Industries Inc |
| Initial Notification | Letter |
| Similar To |