Recall Z-1135-2021— Medline Industries Inc
Class III · Terminated
Class III FDA medical device recall by Medline Industries Inc, initiated 2021-01-15, terminated 2023-01-09. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Medline Industries Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2021-01-15
- Terminated
- 2023-01-09
- Firm location
- Northfield, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.