Medline Industries Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Medline Industries Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Medline Industries Inc is recalling S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative d due to Medline Industries, Inc. is removing specific lots of STAT-Site Controls (Low and High) S-O303000, from the market, due to the product being compromi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Medline sent an "URGENT RECALL NOTIFICATION" on 01/15/2021 to customers, requesting: 1. Immediately check your stock for the affected item number and the affected lot numbers listed on the attachment. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. If you have any questions, please contact 866-359-1704.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026