CLASS II Device recall · Reported 25 Jul 2012 · FDA Enforcement Report
Abbott Molecular Bar Code Scanner User's Guide; instructions recalled
Abbott Molecular is recalling Abbott Molecular Bar, distributed nationwide in the US. The recall was initiated on 31 Jan 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2013-2012
- FDA event ID
- 62329
- Recalling firm
- Abbott Molecular, Des Plaines, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Jan 2012
- FDA classified
- 14 Jul 2012
- Reported
- 25 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 31 Jan 2012 | Recall initiated by company | |
| 14 Jul 2012 | Classified by FDA | +165 days |
| 25 Jul 2012 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
California, Florida, Maryland, Oregon and Virginia, and internationally to Belgium, Brazil, China, France, Germany, Hong Kong, Japan, Malaysia, Mexico, Qatar, Switzerland and United Kingdom
Questions about this recall
Is Abbott Molecular Bar Code Scanner User's Guide; instructions for recalled?
Yes. Abbott Molecular recalled Abbott Molecular Bar Code Scanner User's Guide; instructions for on 31 Jan 2012. The recall is Class II and its status is Terminated. Recall number Z-2013-2012.
Why was it recalled?
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
Which lots are affected?
list numbers 06L88-02, 06L88-03, 06L88-04, 06L88-05, 06L88-06, 06L88-07, 06L88-08 and 06L88-09, all lots
Where was it sold?
California, Florida, Maryland, Oregon and Virginia, and internationally to Belgium, Brazil, China, France, Germany, Hong Kong, Japan, Malaysia, Mexico, Qatar, Switzerland and United Kingdom
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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