Recall Z-2203-2021
Stanbio Laboratory, LP · initiated July 12, 2021
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
Codes / lots: Catalog Number/Product Description: CHB2440180/Cardinal Health ¿-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX Device Identifier: 10885380173141 Lot Numbers: 164986;
Reason for recall
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
FDA-determined cause: Under Investigation by firm
Action taken
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 and retain this notification as part of their laboratory Quality System documentation. 4) If customers have forwarded the product to another laboratory, please provide a copy of this letter to them. Provide the name, address and a contact for the laboratory on the Verification Form. 5) Complete and FAX or email the enclosed Verification Form within 10 days to confirm their receipt of this notice. If you have further questions, please contact Technical Support at 1-800-531-5535 ext. 128.
Details
- Recall number
- Z-2203-2021
- Initiated
- July 12, 2021
- Terminated
- March 29, 2022
- Product code
- JIN – Nitroprusside, Ketones (Urinary, Non-Quant.)
- Quantity
- 93 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.
- Recalling firm
- Stanbio Laboratory, LP, Boerne, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2199-2021 Class III | Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.Deterioration in the stability of the reagents which has resulted in lower than expected or out of range… | 07/12/2021Terminated |
| Z-2200-2021 Class III | Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.Deterioration in the stability of the reagents which has resulted in lower than expected or out of range… | 07/12/2021Terminated |
| Z-2201-2021 Class III | Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.Deterioration in the stability of the reagents which has resulted in lower than expected or out of range… | 07/12/2021Terminated |
| Z-2202-2021 Class III | Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.Deterioration in the stability of the reagents which has resulted in lower than expected or out of range… | 07/12/2021Terminated |