Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro recall
Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
Why was Synchron CX/DX/LX 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: B2440-180/Synchron CX/DX/LX ¿-Hydroxybutyrate LiquiColor Device Identifier: 00657498000526 Lot Numbers: 161020;
- Product
- Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
- Recalling firm
- Stanbio Laboratory, LP
- Quantity
- 100 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)