Recall Z-1811-2018
Tosoh Bioscience Inc · initiated March 5, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.
Codes / lots: All lots.
Reason for recall
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
FDA-determined cause: Nonconforming Material/Component
Action taken
On March 5, 2018, the firm notified all customers who have received product since 2011 of the discontinuation of this product from the market. Customers were instructed to immediately discontinue use of all lot numbers of recalled test and components, remove all recalled materials from inventory, and destroy per the customer's local procedures. Customers were also instructed to notify and forward the information to physicians who have received test results provided by recalled products over the past 6 months to determine if follow up testing is required. Customers were advised that the recalling firm is permanently removing all ST AIA-PACK HbA1c test and components from the market, and were instructed to identify an alternative test option for HbA1c. Customers were asked to complete and return the Recall Acknowledgement Form to the recalling firm. Customers may contact Tosoh Technical Support at 1(800)-248-6764, 8AM-5PM PST (voice mail after hours), seven days a week.
Details
- Recall number
- Z-1811-2018
- Initiated
- March 5, 2018
- Terminated
- June 16, 2020
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Quantity
- 2864
- Distribution
- USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
- Recalling firm
- Tosoh Bioscience Inc, Grove City, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1809-2018 Class II | Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In…The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. | 03/05/2018Terminated |
| Z-1810-2018 Class II | Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended…The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. | 03/05/2018Terminated |
| Z-1812-2018 Class II | Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718…The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. | 03/05/2018Terminated |