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.
FDA Recall Z-1007-2010 · Posted 2010-04-16
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Recalling FirmBD Biosciences, Systems & Reagents
Recall StatusTerminated
Product CodeGKZ
Date Initiated2009-01-29
Date Terminated2011-03-08
Product Quantity17 units
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.
Firm 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.
Root Cause
Package design/selection
Distribution Pattern
Nationwide Distribution -- Including states of WA, MO, NV, CA, NY, PA, AL, and OR.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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