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Coulter AcT 5diff Open Vial Hematology Analyzers recallZ-0039-04 · Beckman Coulter Inc · initiated Sep 8, 2003

Terminated All recalls posted in October 2003

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

Samples with high fat content will not count platelets accurately.

FDA root cause category: Other

What the company is doing

Firm issued an advisory letter to users to retain as part of the Quality Manual for the instruments. It cautions to check specimens for interfering lipemia. Letter was sent 9/8/2003.

Recall details

Recall number
Z-0039-04
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 8, 2003
Posted by the FDA
Oct 15, 2003
Recalling firm
Beckman Coulter Inc
Quantity
36
Product code
GKZ
FDA submissions
K992511
Distribution
United States and Canada

Product description

Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604

Code information (models, lots, serial numbers)

All instruements are affected.

Other devices under the same FDA submission

1 device cleared under K992511 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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