Recall Z-2302-2019 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961
| Date | Jun 12, 2019 |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers. |
| Quantity | 1,436,228,004 total |
| Distribution | Worldwide Distribution, including US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945952 | VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE Bd Becton Dickinson Vacutainer Systems Preanalytic, Jan 18, 1995 |