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Recall Observatory FDA recall evidence

Device product

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

Z-2200-2021

July 12, 2021

Class III

Product summary

Firm
Stanbio Laboratory, LP
Event
Event 88323
Status
Terminated
Classification
Class III
Quantity
200 units
Official record key
device-enforcement:Z-2200-2021

Official wording

Reason: Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Code information: Catalog Number/Product Description: 2441-050U/¿-Hydroxybutyrate Reagent A - Enzyme (unlabeled) Lot Numbers: 158894;

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.