Recall Z-2681-2024 ยท GKZ Counter, Differential Cell
Abbott Laboratories
Alinity hq Analyzer, REF: 09P68-01
| Date | Aug 16, 2024 (initiated Jun 14, 2024) |
| Status | Open, Classified |
| Reason | 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts |
| Root cause | Software design |
| Action | On 6/14/24, correction notices were sent to consignees informing them of the following: 1) Issue 1: Continue to follow the Alinity h-series Operations Manual to verify flagged results. In addition, you must select one of the two options below depending on your laboratory workflow: Option 1: Batch your CBC+DIFF+RETIC samples on an analyzer. Ensure a Background cycle is run prior to processing the next CBC+DIFF sample on that analyzer. OR Option 2: The MCHC for the laboratories are typically set between 31 36 g/dL. In the event your patient sample flags MCHC results greater than the referenc |
| Quantity | 816 |
| Distribution | Worldwide - US Nationwide distribution in the states of NY, OK, NC and the countries of ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, Botswana, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, GREECE, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220031 | Alinity h-series System Abbott Laboratories, Aug 4, 2023 |