Helena Laboratories recalls SPIFE Alkaline Hemoglobin Kit (Cat. No. 3415) due to outdated instructions that could lead to incorrect results. Affected lots include specific 2017 and 2018 production batches with expiration dates up to December 31, 2018.
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.
Helena Laboratories is recalling their SPIFE Alkaline Hemoglobin Kit (Cat. No. 3415) because some versions contain outdated instructions that reference new electrodes not yet available to users. This could lead to incorrect hemoglobin measurements if used without the proper updated equipment.
The kit contains instructions that reference updated parameters for new electrodes which have not been made available to users. This means the instructions could lead to incorrect hemoglobin measurements if the user attempts to follow them without the updated equipment.
Users of the SPIFE Alkaline Hemoglobin Kit for hemoglobin separation and quantitation are most at risk if they follow outdated instructions that reference unavailability of new electrodes. This primarily affects laboratory professionals using the kit for agarose electrophoresis.
Check the lot code on the kit, which is listed as 62-17-551977 through 13-18-551977. The kit was manufactured in 2017 or 2018 with specific expiration dates up to December 31, 2018.
Look for the lot code on the kit, which ranges from 62-17-551977 to 13-18-551977.
The expiration date for Lot 1 through 11 of 2018 is October 31, 2018, and for Lot 12 and 13 of 2018 is December 31, 2018.
The kit contains instructions that reference updated parameters for new electrodes which have not been made available to users, potentially leading to incorrect hemoglobin measurements.
The recall does not require returning the kit; users should check the lot code and ensure they follow the correct instructions for their equipment.
We’ve drafted a message you can send Helena Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-0297-2020 — Helena Laboratories Helena Laboratories Hello, I own a Helena Laboratories that is covered by recall Z-0297-2020 from Helena Laboratories. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
