FDAClass IIIAugust 17, 2016

BD Tritest CD3 FITC/CD4 PE/CD45 PerCP recall

BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium…

Why was BD Tritest CD3 FITC/CD4 PE/CD45 PerCP recalled?

Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer.

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?

Catalog number: 340383; lot No. Expiration Date 49983, 31 July 2016; 01810, 30 September 2016; 82527, 30 September 2016; 54689 , 30 November 2016; 36715 , 31 December 2016; 15614, 31 January 2017; 57797, 28 February 2017.

Product
BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium…
Recalling firm
Becton, Dickinson and Company, BD Biosciences
Quantity
14,089
Distribution
Nationwide distribution to AR, CA, CO, IL, IN, LA, MA, MD, Ml, MN, NC, NJ, NM, NY, OR, PA, TN, TX, WA
Recall date
August 17, 2016
Classification
Class III
Status
Terminated
Agency
FDA (device)
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