FDA Medical Device Recalls (openFDA)
Quantimetrix Corporation: Quantimetrix QuanTscopics Urine Microscopics Control. QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is a bi-level control with stabilized human blood cells provide a means to validate the processing and is centrifugation of urine prior to microscopic analysis in compliance with CLIA regulations.
- Recall number
- Z-0513-2009
- Recalling firm
- Quantimetrix Corporation
- Product
- Quantimetrix QuanTscopics Urine Microscopics Control. QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is a bi-level control with stabilized human blood cells provide a means to validate the processing and is centrifugation of urine prior to microscopic analysis in compliance with CLIA regulations.
- Status
- Terminated
- Initiated
- 2007-06-01
- Posted
- 2009-01-17
- Terminated
- 2009-02-18
- Reason
- This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.
- Root cause
- Employee error
- Action
- The recall communication was initiated when customer both direct and distributors who have purchased the lots were mailed a recall notification letter dated June 8, 2008 with instructions which was sent via first class mail. Customers were requested to assist in the voluntary recall of the listed product and if any of the affected lots have been consumed please review their records to ensure that the obtained values conform to the stated specifications found in the lot specific product insert.
- Quantity
- 24,937 sets for all products.
- Distribution
- Nationwide Distribution including states of AK, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NH, NM, NY, OR, PA, SC, SD, TN, TX, VA, WA and WY.
- Lot, serial or model codes
- Lot Number: 48170, 48171, 48172, 48180, 48181 and 48182.
- 510(k) numbers
- ["K925256"]
- PMA numbers
- not on file
- Product code
- JJY
- Firm FEI
- 2020715
- Firm city
- Redondo Beach
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28