MicroScan WalkAway-40 plus Instrument REF B1018-283
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number: B1018-283 UDI-DI Code: 1509959065866 Serial Numbers: 34010003 34010004 34010005 34010006 34010007 34010008 34010009 34010010 34010011 34010012 34010013 34010014 34010015 34010016 34010017 34010018 34010019 34010020 34010021 34010022 34010023 34010024
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Beckman Coulter Inc.
- Reason for Recall:
- WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
MicroScan WalkAway-40 plus Instrument REF B1018-283
Product Codes/Lot Numbers:
Catalog Number: B1018-283 UDI-DI Code: 1509959065866 Serial Numbers: 34010003 34010004 34010005 34010006 34010007 34010008 34010009 34010010 34010011 34010012 34010013 34010014 34010015 34010016 34010017 34010018 34010019 34010020 34010021 34010022 34010023 34010024
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1083-2022
Related Recalls
Access Total T4 Calibrator, Catalog No. 33805
Beckman Coulter
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.
MicroScan Neg MIC 3J REF C54814
Beckman Coulter
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.