Z-0297-2020Class III

SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by...

Name: Z-0297-2020 SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by...
Creator: Helena Laboratories, Corp.
Published: 2018-02-27
License: https://open.fda.gov/license/

Helena Laboratories, Corp. / initiated 2018-02-27 / Open, Classified / root cause: labeling and UDI

FDA source

Helena Laboratories, Corp. began a recall of SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems on 2018-02-27. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0297-2020
Classification: Class III
Status: Open, Classified
Initiated: 2018-02-27
Posted: 2019-11-05
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
Product code: JBD System, Analysis, Electrophoretic Hemoglobin
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0297-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0297-2020	Class III	Ongoing	Voluntary: Firm initiated	2019-11-13	2019-11-05

Product code JBD

K982426Class IISpife Alkaline HemoglobinHelena Laboratories / cleared 1998-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)