Class III — Stanbio Laboratory, LP
| Recalling firm | STANBIO LABORATORY |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
| Product | Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent. |
| Quantity | 200 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. |
| Initiated | 2021-07-12 |
| Classified | 2021-08-05 |
| Terminated | 2022-03-29 |
| Recall number | Z-2200-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Stanbio Laboratory, LP (Z-2200-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88323/
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