FastPack Total PSA Immunoassay Chemilunescence assay recall
FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle…
Why was FastPack Total PSA 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?
Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.
- Product
- FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle…
- Recalling firm
- Qualigen Inc
- Quantity
- 182
- 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)