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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73655

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 24, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Abbott Laboratories

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1522-2016
Recall number
Z-1522-2016
Initiated
March 24, 2016
Classification
Class II
Status
Terminated
Recalling firm
Abbott Laboratories
Quantity
10,364 plus 9410 additional units for recall expansion.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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.

Distribution pattern

Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Austria, Bosnia & Herze, Cameroon, Egypt, Germany, Indonesia, Iraq, Lebanon, Mali, Montenegro, Netherlands, Philippines, Tanzania, Thailand, UAE, New Zealand, Malaysia, Mexico, South Korea, Jamaica, Turks & Caicos, Italy, Canada, Vietnam, Singapore, Argentina, Colombia, France, Paraguay, Australia, Uruguay, Bahrain, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Ethiopia, Finland, Greece, Switzerland, United Kingdom, Brazil, Hong, Kong, Hungary, India, Ireland, Israel, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Turkey, Jamaica, St. Martin, Nigeria, Oman, Pakistan, Philippines, Poland, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Guatemala, Peru, and Uruguay.