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UniCel DxH 800 Coulter Cellular Analysis System, Catalog… recallZ-1013-2017 · Beckman Coulter Inc. · initiated Dec 19, 2016

Class II Terminated All recalls posted in January 2017

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Beckman Coulter Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. This is due to limitations in the available technology as well as sample limitations.

FDA root cause category: Under Investigation by firm

What the company is doing

Beckman Coulter sent an Urgent Medical Device Recall letter dated December 19, 2016, to all affected customers to inform them that Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. The letter informs the customers of the impact, actions to be taken, and resolution. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Center: http://www.beckmancoulter.com/customersupport/support, 800-526-7694 in the United States and Canada, and outside the United States and Canada, to contact their local Beckman Coulter Representative.

Recall details

Recall number
Z-1013-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 19, 2016
Posted by the FDA
Jan 11, 2017
Recalling firm
Beckman Coulter Inc.
Quantity
4,657 units total (2,067 units in US)
Product code
GKZ
FDA submissions
K081930, K120771, K140911
Distribution
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the countries of : Australia, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Columbia, Croatia, Czech Republic, France, Germany, Gibraltar, Ecuador Hong Kong, India, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, New Zealand, Oman, Panama, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.

Product description

UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304

Code information (models, lots, serial numbers)

Serial Numbers: All

Other devices under the same FDA submission

1 device cleared under K081930, K120771, K140911 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 76044).

Sources and updates

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