—#173995

Product

BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K901449
Affected lot / code info: UDI: (01)30382903666646

Why it was recalled

False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

Root cause (FDA determination)

Device Design

Action the firm took

Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution, including US Nationwide

Timeline

Recall initiated: 2019-06-12
Terminated: 2020-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173995. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.