Reported Nov 13, 2019 · Ongoing

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

Helena Laboratories, Corp.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Helena Laboratories, Corp. · 1530 Lindbergh Dr · Beaumont, TX · 77707-4131

Is this the product you have?

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

Lot codes and dates: 24 of 24 products
Products covered by this recall
# Product as published
1 Lot 62-17-551977 "
2 Lot 63-17-551977 "
3 Lot 64-17-551977 "
4 Lot 65-17-551977 "
5 Lot 66-17-551977 "
6 Lot 67-17-551977 "
7 Lot 68-17-551977 "
8 Lot 69-17-551977 "
9 Lot 70-17-551977 "
10 Lot 71-17-551977 "
11 Lot 72-17-551977 "
12 Lot 1-18-551977, "
13 Lot 2-18-551977 "
14 Lot 3-18-551977 "
15 Lot 4-18-551977 "
16 Lot 5-18-551977 "
17 Lot 6-18-551977 "
18 Lot 7-18-551977 "
19 Lot 8-18-551977 "
20 Lot 9-18-551977 "
Page 1 of 2
Amount recalled: 899 kits

Where it was sold

Why it was 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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

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Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies… Dec 4, 2019
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name… Oct 16, 2019

8 in total.

Where it was distributed

All recall categories · Browse the whole archive

#	Product as published
1	Lot 62-17-551977 "
2	Lot 63-17-551977 "
3	Lot 64-17-551977 "
4	Lot 65-17-551977 "
5	Lot 66-17-551977 "
6	Lot 67-17-551977 "
7	Lot 68-17-551977 "
8	Lot 69-17-551977 "
9	Lot 70-17-551977 "
10	Lot 71-17-551977 "
11	Lot 72-17-551977 "
12	Lot 1-18-551977, "
13	Lot 2-18-551977 "
14	Lot 3-18-551977 "
15	Lot 4-18-551977 "
16	Lot 5-18-551977 "
17	Lot 6-18-551977 "
18	Lot 7-18-551977 "
19	Lot 8-18-551977 "
20	Lot 9-18-551977 "