FDAClass IIIMarch 3, 2021

S-o303000 Control recall

S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate…

Why was S-o303000 Control 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate…
Recalling firm
Medline Industries Inc
Quantity
46 units
Distribution
US Nationwide distribution in the states of MS, OH, IL.
Recall date
March 3, 2021
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls