Recall Z-0665-2022 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog Number: 364902, 36490200
| Date | Jan 6, 2022 |
| Status | Open, Classified |
| Reason | May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts |
| Root cause | Under Investigation by firm |
| Action | BD issued Urgent Medical Device Correction letter via email to Sysmex on January 06, 2022, requesting they inform/distribute to their customers still using a Sysmex UF-1000i or UX-2000 analyzer the notification provided by BD .The scope would include any customers who were shipped Vacutainer LLAD products still using a Sysmex UF-1000i or UX-2000 analyzer. Sysmex issued letter to their customers addressed to the Urinalysis Manager instructs the customer to respond to Sysmex. 1. Sysmex customers should retain a copy of this notification and post near your analyzer as a visual reminder of this |
| Quantity | 288,152,790 Units |
| Distribution | US Nationwide distribution in the state of IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991088 | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE Becton Dickinson Vacutainer Systems, May 28, 1999 |