Z-1135-2021 Class III Terminated
FDA device recall Z-1135-2021 was initiated by Medline Industries Inc on January 15, 2021 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated January 9, 2023). Affected quantity: 46 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 3, 2021
- Initiation Date
- January 15, 2021
- Termination Date
- January 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46 units
Product 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 for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of MS, OH, IL.
Code Information
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.