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Terminated

BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494

FDA Recall Z-2308-2019 · Posted None

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeJKA
Date Initiated2019-06-12
Date Terminated2020-06-29
Product Quantity1,436,228,004 total

Reason for Recall

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.

Firm Action

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

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution, including US Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K945952VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBEBd Becton Dickinson Vacutainer Systems Preanalytic · 1995-01-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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