Z-0516-2009

Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic bottle Synovial fluid cell...

Name: Z-0516-2009 Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic bottle Synovial fluid cell...
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 Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring... 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-0516-2009
Status: Terminated
Initiated: 2007-06-01
Posted: 2009-01-17
Terminated: 2009-02-18
Recalling firm: Quantimetrix Corp.
Product: Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring total cell counts in patient Synovial fluid samples performed manually using a hemocytometer. It is also an aid for identifying the crystals which may indicate a pathological condition present in the Synovial fluid. This control is used as a third party control to confirm proper functioning of the analysis by microscopic evaluation.
Product code: JPK Mixture, Hematology Quality Control
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 Numbers: 38050 and 38060.

Product code JPK

K010598Class IISynovialscopics, Synovial Fluid ControlQuantimetrix Corp. / cleared 2001-03-23

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)