Z-0295-04

POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50...

Name: Z-0295-04 POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50...
Creator: Polymedco, Inc
Published: 2003-12-03
License: https://open.fda.gov/license/

Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC / initiated 2003-12-03 / Terminated / root cause: labeling and UDI

FDA source

Polymedco, Inc began a recall of POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50 Tests. For In Vitro Diagnostic (IVD) use only... on 2003-12-03. The reason FDA records is "Firm was notified by the foreign manufacturer that certain lots of Ultra-CRP are prone to prozone (a condition of antibody antigen excess) and do not meet the labeled specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0295-04
Status: Terminated
Initiated: 2003-12-03
Posted: 2004-01-06
Terminated: 2005-04-20
Recalling firm: Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC
Product: POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50 Tests. For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum.
Product code: DCK C-Reactive Protein, Antigen, Antiserum, And Control
Reason for recall: Firm was notified by the foreign manufacturer that certain lots of Ultra-CRP are prone to prozone (a condition of antibody antigen excess) and do not meet the labeled specifications.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: By phone on 12/3/03 and by mail on 12/5/03.
Quantity in commerce: 165 Kits
Distribution: Medical facilities, physicians, diagnostic laboratories, and distributors located nationwide.
Product codes and lots: Lot numbers CP4274-0769M (EXP. 09/04) and CP4335-0812M (EXP. 11/04)

Product code DCK

K001009Class IIRandox C-Reactive ProteinRandox Laboratories, Ltd. / cleared 2000-08-04

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)