FDA Enforcement
Class III
Terminated
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: Z-1135-2021
·
Reported March 3, 2021
Enforcement
- Recall Number
- Z-1135-2021
- Event ID
- 87184
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medline Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 3, 2021
- Initiation Date
- January 15, 2021
- Classification Date
- February 19, 2021
- Termination Date
- January 9, 2023
- Address
- 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States
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.
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.
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.
Distribution
US Nationwide distribution in the states of MS, OH, IL.
Quantity
46 units