FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0297-2020
- Recalling firm
- Helena Laboratories, Corp.
- Product
- SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
- Status
- Open, Classified
- Initiated
- 2018-02-27
- Posted
- not on file
- Terminated
- not on file
- 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 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.
- 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
- Lot, serial or model codes
- Lot Codes [Scheme: 62(nd lot)-(of 20)17-(for C/N)551977]: " Lot 62-17-551977 " Lot 63-17-551977 " Lot 64-17-551977 " Lot 65-17-551977 " Lot 66-17-551977 " Lot 67-17-551977 " Lot 68-17-551977 " Lot 69-17-551977 " Lot 70-17-551977 " Lot 71-17-551977 " Lot 72-17-551977 " Lot 1-18-551977, " Lot 2-18-551977 " Lot 3-18-551977 " Lot 4-18-551977 " Lot 5-18-551977 " Lot 6-18-551977 " Lot 7-18-551977 " Lot 8-18-551977 " Lot 9-18-551977 " Lot 10-18-551977 " Lot 11-18-551977 " Lot 12-18-551977 " Lot 13-18-551977 The expiration date for all 2017-manufactured lots is 9/30/18. The expiration date for Lot 1 through Lot 11 of 2018 is 10/31/18. The expiration date for Lot 12 and Lot 13 of 2018 is 12/31/18.
- 510(k) numbers
- ["K982426"]
- PMA numbers
- not on file
- Product code
- JBD
- Firm FEI
- 1618982
- Firm city
- Beaumont
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28