Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2013-2012·Announced 2012-07-25

Abbott Molecular Bar Code Scanner User's Guide Recalled for Incorrect Bar Codes

Abbott Molecular is recalling the Bar Code Scanner User's Guide because incorrect bar codes may prevent proper language configuration of the scanner.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a documentation error (incorrect bar codes) that affects device configuration rather than causing direct physical harm or contamination. No illnesses or injuries are reported, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Abbott Molecular is recalling the Bar Code Scanner User's Guide (List Numbers 06L88-02 through 06L88-09) for the Abbott m2000 Instrument System. The recall involves 100 units distributed to clinical laboratories in California, Florida, Maryland, Oregon, and Virginia, as well as internationally to Belgium, Brazil, China, France, Germany, Hong Kong, Japan, Malaysia, Mexico, Qatar, Switzerland, and the United Kingdom.

The recall is due to incorrect bar codes in the section titled "Modifying the Keyboard Format for Bar Code Scanner LN 6L89-01." These errors can prevent the correct configuration of the bar code scanner's language format. The bar code scanner is a hand-held device used to scan sample bar codes for positive sample identification in nucleic acid testing. If the scanner is not configured to match the keyboard language, it may not function as intended.

Users of the Abbott m2000 System should check their User's Guide for the affected list numbers. If the guide contains the incorrect bar codes, users should contact Abbott Molecular for instructions on how to proceed. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product: 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…
Manufacturer: Abbott Molecular
Category: Medical Device — Laboratory Equipment Documentation
Hazard: mis-labeling
documentation-error
Affected units: 100

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

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

Distribution

Distributed in 5 states:

Same manufacturer · Abbott Molecular

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Same hazard · mis labeling