Recall StatusOpen, Classified
Date Initiated2018-02-27
Product Quantity899 kits
Reason for Recall
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.
Firm 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 affect quantitation or interpretation. Please discard the procedural inserts included in the kit received, and replace with the attached procedural insert(s), which contain the same instructions you have historically used:
The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users -- as well as several improvements in the SPIFE Alkaline Hemoglobin gels that we anticipate will be released in the near future.
At that time, additional instructions and information regarding the change will be made available to you.
We apologize for any inconvenience this may have caused. Please contact Technical Services at 1-800-231-5663, EXT 1600 if you have any questions.
Root Cause
Labeling mix-ups
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.