Recall Z-1135-2021
Medline Industries Inc · initiated January 15, 2021
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: 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.
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1135-2021
- Initiated
- January 15, 2021
- Terminated
- January 9, 2023
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Quantity
- 46 units
- Distribution
- US Nationwide distribution in the states of MS, OH, IL.
- Recalling firm
- Medline Industries Inc, Northfield, IL