Food, drugs, devices › Abbott Laboratories
Device recall: CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for
FDA enforcement event 73655 is a device recall by Abbott Laboratories of Santa Clara, CA, initiated 24 Mar 2016 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 4 Jan 2017. Initiation: voluntary: firm initiated. Abbott Laboratories has 46 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Abbott Laboratories, Santa Clara, CA.
Reason for recall
"Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT."
Distribution
"Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Austria, Bosnia & Herze, Cameroon, Egypt, Germany, Indonesia, Iraq, Lebanon, Mali, Montenegro, Netherlands,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1522-2016 | CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The CELL-DYN Emerald Cleaner is an enzymatic cleaner used… | 10,364 plus 9410 additional units for recall expansion. | Class II | Terminated | 27 Apr 2016 |
Context
Other enforcement events for Abbott Laboratories
All 46 events for Abbott Laboratories
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Austria, Bosnia & Herze, Cameroon, Egypt, Germany, Indonesia, Iraq, Lebanon, Mali, Montenegro, Netherlands,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Jan 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.