Beckman Coulter recalls iChem VELOCITY Automated Urine Chemistry Systems with defective seal placement in Strip Provider Modules. Affected units may have manufacturing flaws that could lead to inaccurate test results.
The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.
Beckman Coulter is recalling certain iChem VELOCITY Automated Urine Chemistry Systems due to potential manufacturing defects in the Strip Provider Modules. This could result in inaccurate urine test results if the system is used without proper seal integrity.
The Strip Provider Modules on some units had not been properly inspected for seal placement and integrity during manufacturing. This defect could lead to inaccurate urine test results if the system is used without the correct seal.
Users of the iChem VELOCITY Automated Urine Chemistry System with specific serial numbers are affected. Laboratory personnel and healthcare providers who use these systems for urine testing are most at risk.
Check for the catalog numbers 700-7176-001 or 700-7177-001. Affected units have specific serial numbers: V04494, CV04015 for catalog 700-7176-001 and CV04012, CV04013, CV04014, CV04017 for catalog 700-7177-001.
Identify if your unit has serial numbers V04494, CV04015 (catalog 700-7176-001) or CV04012, CV04013, CV04014, CV04017 (catalog 700-7177-001).
The Strip Provider Modules on some units had not been inspected during manufacturing for correct seal placement and integrity.
Check for the catalog numbers 700-7176-001 or 700-7177-001 and the specific serial numbers listed in the recall notice.
The recall record does not specify a remedy.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1894-2018 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1894-2018 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
