FDA Device recall Z-1522-2016
CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD
- FDA Device
- Class II
- terminated
- Published 2016-04-27
On 2016-04-27 the FDA classified a Class II recall of CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD by Abbott Laboratories, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1522-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-24 |
| Published | 2016-04-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
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 to clean the measurement system and the fluidics.
Reason
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.
Identifiers
| code_info | Lot 6853, Expiration date: 31 JUL2017; Lot 6901, Expiration date: 31JUL2017; Lot 6953, Expiration date: 30SEP2017;…Lot 6853, Expiration date: 31 JUL2017; Lot 6901, Expiration date: 31JUL2017; Lot 6953, Expiration date: 30SEP2017; May 4, 2016 - Firm advised SAN-DO that it has expanded the recall to include three additional lots: Lot 6991, Expiration date: 30NOV2017; Lot 7024, Expiration date: 31DEC2017; Lot: 7027, Expiration date: 31DEC2017. June 28, 2016 - firm added an additional 4 lots to recall: Lot 7044, expiration date 31JAN2018; Lot 7082, expiration date 28FEB2018; Lot 7110, expiration date 31MAR2018; Lot 7119, expiration date 30APR2018. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1522-2016%22
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