CELL-DYN Emerald Cleaner — Class II medical device recall Z-1522-2016
Terminated recall by Abbott Laboratories, reported 2016-04-27, distributed nationwide. Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out o
| Recall number | Z-1522-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Santa Clara, CA, United States |
| Recall initiated | 2016-03-24 |
| Classified | 2016-04-19 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2017-01-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BR, CA, CH, CO, CY, CZ, DE, EG, ES, FI, FR, GB, GR, GT, HR, HU, ID, IE, IL, IN, IQ, IT, JM, KE, KR, KW, LB, LT, LU, LV, MX, MY, NG, NL, NZ, OM, PE, PH, PK, PL, PY, QA, RO, RS, RU, SA, SG, SI, SK, TH, TR, UY, VN |
| Lot numbers | 6853, 6901, 6953, 6991, 7024, 7027, 7044, 7082, 7110, 7119 |
| Expiration dates | 2017-07-31, 2017-09-30, 2017-11-30, 2017-12-31, 2018-01-31, 2018-02-28, 2018-03-31, 2018-04-30 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1522-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.