Reported Apr 27, 2016 · Terminated
CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for…
Abbott Laboratories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Laboratories · 4551 Great America Pkwy · Santa Clara, CA · 95054-1208
Is this the product you have?
- CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD
- HematologyThe 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
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 Lot 6901, Expiration date: 31JUL2017 2 Lot 6953, Expiration date: 30SEP2017; May 4, 2016 - Firm advised SAN-DO that it has expanded the recall to include three additional lots 3 Lot 6991, Expiration date: 30NOV2017 4 Lot 7024, Expiration date: 31DEC2017 5 Lot: 7027, Expiration date: 31DEC2017. June 28, 2016 - firm added an additional 4 lots to recall 6 Lot 7044, expiration date 31JAN2018 7 Lot 7082, expiration date 28FEB2018 8 Lot 7110, expiration date 31MAR2018 9 Lot 7119, expiration date 30APR2018. - Amount recalled
- 10,364 plus 9410 additional units for recall expansion.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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