SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
Reported: November 13, 2019 Initiated: February 27, 2018 #Z-0297-2020
Product Description
SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
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.
Details
- Recalling Firm
- Helena Laboratories, Corp.
- Units Affected
- 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
- Location
- Beaumont, TX
Frequently Asked Questions
What product was recalled? ▼
SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems. Recalled by Helena Laboratories, Corp.. Units affected: 899 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2019. Severity: Low. Recall number: Z-0297-2020.
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