Medical Device Recall: Z-0003-05

FDA Recalls dataset · Firm: ABX Diagnostics Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-08-13 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0003-05.

Recall Res Number
Z-0003-05
Recalling Firm / Manufacturer
FEI Number
3002698356
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-08-13
Date Posted
2004-10-05
Date Terminated
2005-09-02
Product Code
GKZ
Event Number
29830
Product Quantity
3
Product Description Automated Differential Cell Counter

Reason for Recall Device can generate overestimated platelet results.

Action Details Software problem, device may give overestimated platelet results.

Distribution Pattern Nationwide

Code Information / Serial Numbers Part Numbers: Pentra 80XL P80XL000NUA10

Related Establishments / Registrations

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

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