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Stanbio Laboratory, LP Recall 88323

Description: Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.

Stanbio Laboratory, LP Recall 88323 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2200-2021
Event ID88323
Event DescriptionBeta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
Product TypeDevices
DistributionWorldwide 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.
Quantity200 units
Recall ReasonDeterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Device Classification20210811
Device Code InfoCatalog Number/Product Description: 2441-050U/¿-Hydroxybutyrate Reagent A - Enzyme (unlabeled) Lot Numbers: 158894;
Center Classification Date20210805
Recall Initiation Date20210712
Recalling FirmStanbio Laboratory, LP
Initial Notification Letter
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