Recall Z-2434-2019 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Helena Laboratories, Inc.
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
| Date | Oct 14, 2016 |
| Status | Terminated |
| Reason | Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range. |
| Root cause | Process control |
| Action | Between 10/14/2016 to 10/21/2016 a notification was emailed to the affected users informing them that Assay protocol had changed due to a Marketing decision to delete use of EDC, since it was a discontinued device (for over 10 years), creating a tighter assay range, but met QC specification. Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range, Technical Services began an MRA investigation. Investigation verified user complaint, and Lot was quarantined, and Rework action plans using EDC also were initiated for the device. T |
| Quantity | 65 kits |
| Distribution | Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K821982 | TITAN GEL SERUM CONTROL Helena Laboratories, Aug 16, 1982 |