Recalls / —
—#173881
Product
The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
- FDA product code
- CGR — Radioimmunoassay, Cortisol
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K023764, K050202
- Affected lot / code info
- Lot Number 831755.
Why it was recalled
Cross contamination may have occurred between wells for the reagent pack. As a result of this defect, patient results may be negatively impacted (falsely decreased) by up to 16%).
Root cause (FDA determination)
Process design
Action the firm took
An Urgent Medical Device Recall Letter was sent during the week of 9/17/2018 to all affected customers via mail and or email. Customers were instructed to discontinue use and discard remaining product. Customers were also instructed to consider a review of the Cortisol results generated with the affected lot number at the discretion of the Medical Director.
Recalling firm
- Firm
- Beckman Coulter Inc.
- Address
- 250 S Kraemer Blvd, Brea, California 92821-6232
Distribution
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Canada, Lithuania, Mexico, Panama, Serbia, South Africa, and Vietnam.
Timeline
- Recall initiated
- 2018-09-18
- Terminated
- 2024-02-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #173881. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.