FDA Device recall Z-0297-2020
SPIFE Alkaline Hemoglobin Kit, Cat
- FDA Device
- Class III
- ongoing
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class III recall of SPIFE Alkaline Hemoglobin Kit, Cat by Helena Laboratories, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0297-2020 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2018-02-27 |
| Published | 2019-11-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Helena Laboratories |
| Distribution | AZ, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NJ, NY, OH, PA, SC, TX, VA, WA, WI |
Product
SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
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.
Identifiers
| code_info | Lot Codes [Scheme: 62(nd lot)-(of 20)17-(for C/N)551977]: " Lot 62-17-551977 " Lot 63-17-551977 " Lot 64-17-55197…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0297-2020%22
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