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
- Recall Number
- Z-1135-2021
- Event Number
- 87184
- Firm
- Medline Industries Inc
- FEI Number
- 1417592
- Product Code
- JJX
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- January 15, 2021
- Terminated
- January 9, 2023
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753
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. is removing specific lots of STAT-Site Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.
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.
US Nationwide distribution in the states of MS, OH, IL.
46 units