Reported Oct 16, 2019 · Terminated
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena…
Helena Laboratories, Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
- Lot codes and dates
Lot 35-17-552583exp. date 4/30/2018
- Amount recalled
- 24 kits
Where it was sold
Why it was recalled
The plates do not have wells punched for the controls in the patient 1 area.
This product could cause temporary or reversible health problems — stop using it.
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