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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Beckman Coulter Inc.: Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.

Agency Publication Date: April 7, 2021
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Affected Products

Product: MicroScan WalkAway-40 plus Instrument

Catalog Number: B1018-283 UDI Code: 1509959065866 Serial Numbers: 34010001 34010002 34010003 34010004 34010005 34010006 34010007 34010008 34010009 34010010 34010011 34010012 34010013 34010014 34010015 34010016

Lot Numbers:
1509959065866
Product: MicroScan WalkAway-96 plus Instrument

Catalog Number: B1018-284 UDI Code: 15099590658687 Serial Numbers: 39610001 39610002 39610003 39610004 39610005 39610006 39610007 39610008 39610009 39610010 39610011 39610012

Lot Numbers:
15099590658687
Product: MicroScan WalkAway-40 plus Reconditioned Instrument

Catalog Number: B1018-340R UDI Code: 15099590684112 Serial Numbers: 34020035 34020224 34030054 3407179 3407459 3407532

Lot Numbers:
15099590684112
Product: MicroScan WalkAway-96 plus Reconditioned Instrument

Catalog Number: B1018-396R UDI Code: 15099590684129 Serial Numbers: 3967245 3967417 3967493 3967544 3967634 3967734 3967914 3928224 3968442

Lot Numbers:
15099590684129

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87486
Status: Resolved
Manufacturer: Beckman Coulter Inc.
Manufactured In: United States
Units Affected: 4 products (16 systems; 12 systems; 6 systems; 9 systems)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.