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Recall Observatory FDA recall evidence

Device product

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

Z-0297-2020

February 27, 2018

Class III

Product summary

Firm
Helena Laboratories, Corp.
Event
Event 83925
Status
Ongoing
Classification
Class III
Quantity
899 kits
Official record key
device-enforcement:Z-0297-2020

Official wording

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.

Code information: 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.

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.