Z-1140-2018Class I

BD Vacutainer EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)

Name: Z-1140-2018 BD Vacutainer EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)
Creator: Becton Dickinson & Company
Published: 2018-03-22
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-03-22 / Terminated / root cause: design

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551) on 2018-03-22. FDA classified it as Class I and gives the reason as "BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays, employing...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1140-2018
Classification: Class I
Status: Terminated
Initiated: 2018-03-22
Posted: 2018-03-22
Terminated: 2022-07-25
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays, employing the Anodic Stripping Voltammetry (ASV) methodology, or any other assay employing ASV methodology.
Root cause tag: design
FDA root cause: Device Design
Action: On March 22, 2018, BD issued a press release. BD intends to distribute URGENT MEDICAL DEVICE CORRECTION notices to their customers in the upcoming days via courier service. The URGENT MEDICAL DEVICE CORRECTION notification has been posted on BD's website along with a link to their press release. BD has updated the IFU for BD Vacutainer EDTA and BD Vacutainer Lithium Heparin Tubes to include the noted precaution for use of Lavender, Tan, Pink and Green Top tubes on Magellan Diagnostics Leadcare assays using ASV methodology. **Distributors are advised to Take the Following Actions: 1) This is a Medical Device Correction and there is no need to return or discard product. The product can continue to be used with other non-ASV blood lead level test technologies such as GFAAS and ICP-MS and all assays which do not employ ASV methodology. 2) If you have distributed this product, please identify your customers and notify them of this recall by sharing a copy of the correction notice. 3) Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the covered product. 4) If you would like BD to conduct the notification to your customers, please email your customer list within 3 business days to [email protected]. Please include the contact name, address, phone number, email address, and/or fax numbers for each customer. Distributors who require further assistance, please contact BD at 1-888-237-2762 (select Option #3 and then Option # 4) between 8AM and 5 PM, CT Monday through Friday. **Medical Directors, Risk Managers, Medical Device Safety Officers & Lab Managers are advised to Take the Following Actions: 1) This is a Medical Device Correction and there is no need to return or discard product. The product can continue to be used with other non-ASV blood lead level test technologies such as GFAAS and ICP-MS and all assays which do not employ ASV methodology. 2) Continue to follow FDA's safety
Quantity in commerce: 3,956,900
Distribution: Distributed in 46 states: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Puerto Rico.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1140-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1139-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-22
Z-1140-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-22
Z-1141-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-22
Z-1142-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-22

Product code JKA

K971449Class IIVacutainer Brand Plus Tube with Edta Anticoagulant(multiple)Becton Dickinson Vacutainer Systems / cleared 1997-06-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)