FDA Medical Device Recalls (openFDA)
Polymedco, Inc: POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x 6 ML R2. R1 is the HIGH SENSITIVE CRP Buffer IVD (50 ml). R2 is the HIGH SENSITIVE CRP Latex IVD (6 ml). For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum
- Recall number
- Z-0296-04
- Recalling firm
- Polymedco, Inc
- Product
- POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x 6 ML R2. R1 is the HIGH SENSITIVE CRP Buffer IVD (50 ml). R2 is the HIGH SENSITIVE CRP Latex IVD (6 ml). For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum
- Status
- Terminated
- Initiated
- 2003-12-03
- Posted
- 2004-01-06
- Terminated
- 2005-04-20
- Reason
- 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
- Other
- Action
- By phone on 12/3/03 and by mail on 12/5/03.
- Quantity
- 584 Kits
- Distribution
- Medical facilities, physicians, diagnostic laboratories, and distributors located nationwide.
- Lot, serial or model codes
- Lot numbers 1155J (EXP. 09/04) and 1388J (EXP. 10/04)
- 510(k) numbers
- ["K001009"]
- PMA numbers
- not on file
- Product code
- DCK
- Firm FEI
- 1000119795
- Firm city
- Cortlandt Manor
- Firm state
- NY
- 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