—#185504

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.

FDA product code: JJX — Single (Specified) Analyte Controls (Assayed And Unassayed)
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / 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.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution in the states of MS, OH, IL.

Timeline

Recall initiated: 2021-01-15
Terminated: 2023-01-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185504. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.