27

Jun

2007

Inc., Class II Abbott Laboratories

0

Company:Abbott Laboratories, Inc.,
Date of Enforcement Report:6/27/2007
Class:ll

PRODUCT
) ARCHITECT i2000 Processing Module, for in vitro diagnostics;
List Number 8C89-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30,
v2.60 and v3.00; Recall # Z-0950-2007;
b) ARCHITECT i2000sr Processing Module, for in vitro diagnostics;
List Number: 3M74-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30,
v2.60 and v3.00; Recall # Z-0951-2007;
c) ARCHITECT c8000 Processing Module, for in vitro diagnostics;
List Number: 1G06-01; Affected software: v2.10, v2.11, v2.12,
v2.20, v2.20DB, v2.30, v2.60 and v3.00; Recall # Z-0952-2007;
d) ARCHITECT c16000 Processing Module, for in vitro diagnostics;
List Number: 3L77-01; Affected software: v2.10, v2.11, v2.12,
v2.20, v2.20DB, v2.30, v2.60 and v3.00; Recall # Z-0953-2007

REASON
One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays requiring a standard sample dilution. 3) Infrequent data may be missing from automatically or manually printed reports generated on the Architect system. 4) Clinical Chemistry Assays using the Spline Math Model may be unflagged but decreased (affects both Abbott and open system assays for Architect c System).

CODE
All serial numbers

RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letters on April 30, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3344 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

Agile principles that align well with medical
Backlog management
Agile risk management
Incremental and iterative software development lifecycle management
Frequent release management
And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offering: Dec 3, 4, & 5, 2024 – 12:00 pm to 5:00 pm CET

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering: TBD

Call or email now to schedule a private, in-house class. The fall schedule is filling up!

Email training@softwarecpr.com to request a special pre-registration discount. Limited number of pre-registration coupons.

Registration Link:

TBD

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering: TBD