Titan Gel Serum Protein Control: SPE Control recall
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Why was Titan Gel Serum Protein Control: SPE Control recalled?
Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
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?
Lot Codes: 1-16-5136 (Scheme: 1(st lot)-(of 20)16-(for C/N )5136) LOT 1-16-5136 EXP 3-17 Model/Catalog Number: 5136 UDI: Primary DI - M52551360
- Product
- Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
- Recalling firm
- Helena Laboratories, Inc.
- Quantity
- 65 kits
- Distribution
- Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea
- Recall date
- September 11, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)