FDAClass IIDecember 25, 2013

FastPack Free T4 Immunoassay Chemilunescence assay for recall

FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle…

Why was FastPack Free T4 Immunoassay Chemilunescence assay for 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 25000043. Lot Number 1310028-2P.Exp Date: 4/10/2014

Product
FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle…
Recalling firm
Qualigen Inc
Quantity
17
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