Recall Z-1383-2019 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity capabilities. DxH 800 intended use states: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyze
| Date | May 23, 2019 (initiated Jul 30, 2018) |
| Status | Terminated |
| Reason | Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized. |
| Root cause | Software Design Change |
| Action | Urgent Medical Device Recall letters, dated July 30, 2018, were sent via email and postal mail on August 1, 2018 (for those customers not on their email notification system). On 05/22/19, second Urgent Medical Device (UMDC) Recall letters, and Important Safety Information notices, dated May 20, 2019 (replacing BEC UMDC letter dated July 30, 2018), were sent via mail and/or phone and/or e-mail informing customers perform the following actions: - Run samples on an instrument not subject to this recall to confirm the platelet results. - If an alternative instrument is not available, use the f |
| Quantity | 2,059 devices |
| Distribution | Worldwide Distribution - US Nationwide including Puerto Rico. There was government and military distribution. Foreign distribution was made to Andorra, Australia, Austria, Belgium, Canada, China, Croatia, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Kuwait, Latvia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140911 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM Beckman Coulter, Inc., Sep 5, 2014 |