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Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner ...

FDA Device Recall #Z-2013-2012 — Class II — January 31, 2012

Recall Summary

Recall Number Z-2013-2012
Classification Class II — Moderate risk
Date Initiated January 31, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Abbott Molecular
Location Des Plaines, IL
Product Type Devices
Quantity 100 units

Product Description

Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02. Language configuration bar codes - Intended Use: The bar code scanner is a hand-held device that provides a convenient means of scanning sample bar codes to allow positive sample identification and is supplementary to the computer keyboard. Both the scanner and the keyboard transmit data to a System Control Center (SCC) through a single wedge (cable with branched connectors). The bar code scanner must be configured to match the keyboard language being used. In its default configuration set by the manufacturer (Jadak), the scanner is in English format. If a keyboard other than the English keyboard is being used, the user is required to use the scanner to scan an appropriate language configuration bar code provided in the User's Guide to match the language of the keyboard. Users in the U.S have the ability to convert to another language.

Reason for Recall

In the Abbott Molecular Bar Code Scanner User's Guide, List Number 6L88-02/09, the section Modifying the Keyboard Format for Bar Code Scanner LN 6L89-01 contains incorrect bar codes that can prevent the correct configuration of the bar code scanner language format. The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories. It is comprised of the Ab

Distribution Pattern

California, Florida, Maryland, Oregon and Virginia, and internationally to Belgium, Brazil, China, France, Germany, Hong Kong, Japan, Malaysia, Mexico, Qatar, Switzerland and United Kingdom

Lot / Code Information

list numbers 06L88-02, 06L88-03, 06L88-04, 06L88-05, 06L88-06, 06L88-07, 06L88-08 and 06L88-09, all lots

Other Recalls from Abbott Molecular

Recall # Classification Product Date
Z-0463-2015 Class II Abbott m2000sp, an automated system for perform... Oct 23, 2014
Z-2169-2014 Class II 5 mL Reaction Vessels (a consumable of the Abbo... Jun 19, 2014
Z-0948-2015 Class II The Abbott m2000sp is an automated system for p... Nov 23, 2013
Z-1491-2014 Class III The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20u... Mar 28, 2013
Z-0634-2013 Class II Abbott m2000sp Instrument; an automated fluid h... Dec 4, 2012

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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