Cardinal Health Beta-Hydroxybutyrate . in vitro recall
Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
Why was Cardinal Health Beta-Hydroxybutyrate . in vitro recalled?
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
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?
Catalog Number/Product Description: CH2440058/Cardinal Health ¿-Hydroxybutyrate LiquiColor Device Identifier: 10885380173127 Lot Numbers: 166355; 165053; 163944; 162092;
- Product
- Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
- Recalling firm
- Stanbio Laboratory, LP
- Quantity
- 3,940 units
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Chile, Federal Republic of Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Viet Nam.
- Recall date
- August 11, 2021
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)