The Recall Desk

Manufacturer

Abbott Molecular

6 recalls in our database name Abbott Molecular as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2015-01-21

Of the 6 recalls from Abbott Molecular we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • HighFDA (Devices)·Z-0948-2015·2015-01-21

    Abbott m2000sp Automated Sample Preparation System Recalled for X-Drive Failure

    Abbott Molecular is recalling 176 m2000sp automated sample preparation systems because the x-drive assembly may fail prematurely, potentially causing the manipulator arm to contact objects or pipet improperly.

    Product
    The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
    Category
    Medical Device
    Distribution
    12 states
  • LowFDA (Devices)·Z-0463-2015·2014-12-03

    Abbott m2000sp Software Incompatibility Recall for Nucleic Acid Testing

    Abbott Molecular is recalling m2000sp CD-ROMs because some Application Specifications are incompatible with software versions 6.0 and 7.0, causing error code 9000.

    Product
    Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2169-2014·2014-08-20

    Abbott 5 mL Reaction Vessels Recalled for Insufficient Rim Defect

    Abbott Molecular is recalling 5 mL Reaction Vessels for the m2000sp system because an insufficient rim may cause the vessels to drop through the carrier.

    Product
    5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1491-2014·2014-04-30

    Abbott Molecular Recalls CEP 8 Probe Kits Containing Incorrect Probe

    Abbott Molecular is recalling 20 kits of CEP 8 SG ASR Probe that contained the wrong probe. The kits contained Vysis CEP 4 probe instead of the expected CEP 8 probe.

    Product
    The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that hybridiz
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0634-2013·2013-01-09

    Abbott m2000sp Instrument Software Recall for Data Saving Error

    Abbott Molecular is recalling m2000sp Instruments due to a software issue where changes to control or calibrator information are not saved.

    Product
    Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2013-2012·2012-07-25

    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.

    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 U
    Category
    Medical Device
    Distribution
    5 states