Z-1007-2010

BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P/N: 340166, Product...

Name: Z-1007-2010 BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P/N: 340166, Product...
Creator: BD Biosciences, Systems & Reagents
Published: 2009-01-29
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2009-01-29 / Terminated / root cause: packaging

FDA source

BD Biosciences, Systems & Reagents began a recall of BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P/N: 340166, Product is manufactured and distributed by BD... on 2009-01-29. The reason FDA records is "The product is mislabeled, in that, zero/low controls were mislabeled as medium/high, and the medium/high controls were labeled zero/low". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1007-2010
Status: Terminated
Initiated: 2009-01-29
Posted: 2010-04-16
Terminated: 2011-03-08
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P/N: 340166, Product is manufactured and distributed by BD Biosciences, San Jose, CA The reagents are for in vitro diagnostic use on a BD FACSCount instrument.
Product code: GKZ Counter, Differential Cell
Reason for recall: The product is mislabeled, in that, zero/low controls were mislabeled as medium/high, and the medium/high controls were labeled zero/low.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: On 1/29/09, the firm initiated the recall and its notification was via Important Product Information letters identifying the affected product and explaining the reason for the recall. Customers who experienced error codes with the affected product were to contact their local BD Biosciences representative or distributor to receive replacement BD FACSCount controls.
Quantity in commerce: 17 units
Distribution: Nationwide Distribution -- Including states of WA, MO, NV, CA, NY, PA, AL, and OR.
Product codes and lots: Lot Number: 89031721

Product code GKZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)