Medline Recalls STAT-Site B-HB Controls Due to Shipment Compromise
Medline Industries is recalling specific lots of STAT-Site B-HB controls because the products were compromised during shipment. The recall affects 46 units distributed in Mississippi, Ohio, and Illinois.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a shipment compromise without reported injuries or illnesses.
Plain-English summary
Medline Industries, Inc. is removing specific lots of STAT-Site Controls (Low and High), model number S-O303000, from the market. The recall is being conducted because the product was compromised during shipment. The affected product is intended for the quantitative determination of the ketone body β-Hydroxybutyrate in serum or plasma and is for laboratory use only.
The recall involves 46 units with batch numbers 154950, 154590, 158668, 159370, 192532, 192891, 19365, and 200831. These units were distributed nationwide in the states of Mississippi, Ohio, and Illinois.
No specific instructions for consumers or healthcare providers are provided in the source text regarding how to return the product or what immediate actions to take beyond the removal from the market.
The recalled product
- 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.
- Manufacturer
- Medline Industries Inc
- Hazard
- Affected units
- 46
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Model Number: S-O303000
- Batch Numbers: 154950
- 154590
- 158668
- 159370
- 192532
- 192891
- 19365
- 200831
- Lot Number and/or Serial Number: 154950
- 200831.
Distribution
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