Reported Sep 11, 2019 · Terminated
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Helena Laboratories, Inc.
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, Inc. · 1530 Lindbergh Dr · Beaumont, TX · 77707-4131
Is this the product you have?
- Titan Gel Serum Protein ControlSPE Control Cat. No 5136 1 x 2.0 mL
- Lot codes and dates
- Lot Codes1-16-5136 (Scheme: 1(st lot)-(of 20)16-(for C/N )5136) LOT 1-16-5136
- EXP 3-17 Model/Catalog Number5136
- UDIPrimary DI - M52551360
- Amount recalled
- 65 kits
Where it was sold
Why it was recalled
Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
This product could cause temporary or reversible health problems — stop using it.
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