Recall Z-2200-2021 ยท JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Stanbio Laboratory, LP
Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
| Date | Jul 12, 2021 |
| Status | Terminated |
| Reason | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
| Root cause | Under Investigation by firm |
| Action | On 07/12/2021, the firm sent an "PRODUCT CORRECTION NOTIFICATION" Letter via First Class mail (U.S.) and email (O.U.S.) to inform customers that the Recalling Firm has observed deterioration in the stability of the liquid reagents which has resulted in lower than expected or out of range Quality Control values. Customers are instructed to: 1) Discontinue use of and quarantine any affected product. 2) Only the lot listed in the table provided are affected and customers may continue to use any other lots they may have in their possession. 3) Share this information with their laboratory staff an |
| 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, Federa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910108 | GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED Gds Diagnostics, Mar 4, 1991 |