Device 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.
Z-1135-2021
Product summary
- Event
- Event 87184
- Status
- Terminated
- Classification
- Class III
- Quantity
- 46 units
- Official record key
device-enforcement:Z-1135-2021
Official wording
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 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.
Distribution pattern: US Nationwide distribution in the states of MS, OH, IL.
Derived failure modes
-
Unknown
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.