CLASS III ONGOING Device recall · Reported 13 Nov 2019 · FDA Enforcement Report

Spife Alkaline Hemoglobin Kit recalled by Helena Laboratories

Helena Laboratories is recalling Spife Alkaline Hemoglobin Kit, distributed in 22 states. The recall was initiated on 27 Feb 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot 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.

Quantity recalled899 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0297-2020
FDA event ID: 83925
Recalling firm: Helena Laboratories, Beaumont, TX
Classification: Class III
Status: Ongoing
Recall initiated: 27 Feb 2018
FDA classified: 5 Nov 2019
Reported: 13 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

27 Feb 2018	Recall initiated by company
5 Nov 2019	Classified by FDA	+616 days
13 Nov 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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

Arizona Connecticut Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Maryland Michigan Missouri Mississippi New Jersey New York Ohio Pennsylvania South Carolina Texas Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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