Stanbio Laboratory, LP Recall 88323
Description: Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
Stanbio Laboratory, LP Recall 88323 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2200-2021 |
| Event ID | 88323 |
| Event Description | Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent. |
| Product Type | Devices |
| 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. |
| Quantity | 200 units |
| Recall Reason | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
| Device Classification | 20210811 |
| Device Code Info | Catalog Number/Product Description: 2441-050U/¿-Hydroxybutyrate Reagent A - Enzyme (unlabeled) Lot Numbers: 158894; |
| Center Classification Date | 20210805 |
| Recall Initiation Date | 20210712 |
| Recalling Firm | Stanbio Laboratory, LP |
| Initial Notification | Letter |
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