Recall Z-0297-2020 ยท JBD System, Analysis, Electrophoretic Hemoglobin
Helena Laboratories, Corp.
SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
| Date | Feb 27, 2018 |
| Status | Open, Classified |
| Reason | Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users. |
| Root cause | Labeling mix-ups |
| Action | On 2/27/2018, Helena's Technical Services contacted customer via phone call. In addition, consignees were emailed the recall notification. During the call/ communicated the following We would like to make you aware that you recently received a lot of SPIFE Alkaline Hemoglobin Gel kits, Catalog number 551977, which contained a revised procedural insert. This procedural version was released earlier than intended. The kits affected include the following lots: If you utilized the new testing parameters in the kit, the only noticeable effects would be increased pattern lengths, which would not |
| Quantity | 899 kits |
| Distribution | US: OH, NY, MI, IN, IL, MS, TX, CT, NJ, KY, FL, MD, GA, PA, AZ, MO, VA, SC, LA, KS, WA, WI, OUS: Colombia, Brasil, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982426 | SPIFE ALKALINE HEMOGLOBIN Helena Laboratories, Dec 17, 1998 |