Z-0513-2009

Quantimetrix QuanTscopics Urine Microscopics Control. QuanTscopics is a plastic bottle liquid urine...

Name: Z-0513-2009 Quantimetrix QuanTscopics Urine Microscopics Control. QuanTscopics is a plastic bottle liquid urine...
Creator: Quantimetrix Corporation
Published: 2007-06-01
License: https://open.fda.gov/license/

Quantimetrix Corp. / initiated 2007-06-01 / Terminated / root cause: manufacturing process

FDA source

Quantimetrix Corporation began a recall of Quantimetrix QuanTscopics Urine Microscopics Control. QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is a bi-level control with... on 2007-06-01. The reason FDA records is "This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0513-2009
Status: Terminated
Initiated: 2007-06-01
Posted: 2009-01-17
Terminated: 2009-02-18
Recalling firm: Quantimetrix Corp.
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.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot Number: 48170, 48171, 48172, 48180, 48181 and 48182.

Product code JJY

K925256Class IQuantimetrix Urinalysis Microscopics ControlQuantimetrix Corp. / cleared 1993-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)