Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
Reported: August 11, 2021 Initiated: July 12, 2021 #Z-2201-2021
Product Description
Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
Reason for Recall
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Details
- Recalling Firm
- Stanbio Laboratory, LP
- Units Affected
- 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.
- Location
- Boerne, TX
Frequently Asked Questions
What product was recalled? ▼
Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.. Recalled by Stanbio Laboratory, LP. Units affected: 100 units.
Why was this product recalled? ▼
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 11, 2021. Severity: Low. Recall number: Z-2201-2021.
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