FDA Medical Device Recalls (openFDA)
Pointcare Technologies, Inc.: PointCare NOW CD4NOW Gold Reagent Pack, or Gold Pack, Part Number :30034 In Vitro Diagnostic : Assay reagent intended for use on the PointCare NOW In Vitro Diagnostics Instrument to provide CD4 positive lymphocytes cell count
- Recall number
- Z-1193-2012
- Recalling firm
- Pointcare Technologies, Inc.
- Product
- PointCare NOW CD4NOW Gold Reagent Pack, or Gold Pack, Part Number :30034 In Vitro Diagnostic : Assay reagent intended for use on the PointCare NOW In Vitro Diagnostics Instrument to provide CD4 positive lymphocytes cell count
- Status
- Terminated
- Initiated
- 2011-11-02
- Posted
- 2012-03-08
- Terminated
- 2012-04-26
- Reason
- Stability not assured at labeled temperature 2-42C
- Root cause
- Storage
- Action
- The firm, PointCare, issued a "Customer Service Advisory (CSA-00016)" dated November 2, 2011 to its customers to inform them of the new storage requirements of 2-30C as opposed to the previously claimed 2-42C. The letter describes the product, problem and action to be taken. The customers were instructed to correct the labeling on any Gold Reagent Packs and Gold Reagent and ensure that the Gold Reagent Packs and Gold Reagent they currently have in stock is stored within the 2-30C storage range. Future lots will be labeled with the updated storage temperatures. A member of our customer support team will provide additional information relative to this advisory. Should you have any questions or require further assistance, you may email us at customersupport@pointcare.net or call our offices directly at 1-508-281-6925.
- Quantity
- 463 packs
- Distribution
- International only: including countries of : Abuja, Haiti, Indonesia, Natal, Nigeria, Senegal, South Africa, Uganda, and United Kingdom.
- Lot, serial or model codes
- Lot Numbers:KG13230, KG13231, KG21520 and KG21521
- 510(k) numbers
- ["K072869"]
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 3004086182
- Firm city
- Marlborough
- Firm state
- MA
- 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