Z-0171-2016Class III

BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon...

Name: Z-0171-2016 BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon...
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2015-09-30
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2015-09-30 / Terminated / root cause: labeling and UDI

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR)... on 2015-09-30. FDA classified it as Class III and gives the reason as "Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0171-2016
Classification: Class III
Status: Terminated
Initiated: 2015-09-30
Posted: 2015-11-04
Terminated: 2016-10-18
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.
Product code: LIZ Assay, T Lymphocyte Surface Marker
Reason for recall: Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: BD sent an "URGENT PRODUCT RECALL" letter dated September 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer Actions: 1. Discard all remaining stock of CD3 (SK7) FITC, catalog number 349201, lot number 5148598, and/or catalog number 340542, lot number 5113983, and request replacement product. BD will replace product at no cost. 2.As a requirement of our Regulatory Tracking Process, we request that you complete the enclosed Tracking Verification form, even if you no longer have the affected reagents listed in your inventory. Please return the Tracking Verification form to BD Biosciences, per the instructions (mail, fax, or email). We apologize for any inconvenience that this may have caused and are working toward a long-term solution to this issue. If you require further assistance, please contact BD Customer Support at 877.232.8995 (prompt 3, 3) in the United States. For customers outside the US, contact your local BD Biosciences representative or distributor.
Quantity in commerce: 120 units
Distribution: US (nationwide) Distribution to the states of : TX, GA, IN, TN, CA, KY, WA, IL, MO, NY, CT, MN, NV, KS, WI, NH, FL, PA, OH, OR, SC. OK, NC and LA., and Internationally to Mexico.
Product codes and lots: Catalog Number: 349201; Lot Number 5148598 (expires 10-31-2016) Catalog Number: 340542; Lot Number 5113983 (expires 02-28-2017)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0171-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0171-2016	Class III	Terminated	Voluntary: Firm initiated	2015-11-04	2015-10-27

Product code LIZ

K842218Class IIAnti-Leu-4 Fitc Lysin C BufferBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1984-12-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)