—#162680

Product

BD Vacutainer Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI: 50382903666640); 2. 367884 (UDI: 50382903678841); 3. 367886 (UDI: 50382903678865); 4. 368040 (UDI: 50382903680400); 5. 366667 (UDI: 50382903666671); 6. 367880 (UDI: 50382903678803)

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K160657
Affected lot / code info: All lots. Catalog Number (Shelf Life): 1. 366664 (Requested); 2. 367884 (Requested); 3. 367886 (Requested); 4. 368040 (Requested); 5. 366667 (Requested); 6. 367880 (Requested)

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 BDPASRC@bd.com. 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

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2018-03-22
Posted by FDA: 2018-03-22
Terminated: 2022-07-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162680. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.