FDAClass IIDecember 25, 2013

FastPack Testosterone Immunoassay Chemilunescence assay recall

FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic…

Why was FastPack Testosterone Immunoassay Chemilunescence assay recalled?

Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014

Product
FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic…
Recalling firm
Qualigen Inc
Quantity
18
Distribution
US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
Recall date
December 25, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls