Z-1193-2012

PointCare NOW CD4NOW Gold Reagent Pack, or Gold Pack, Part Number :30034 In Vitro Diagnostic : Assay reagent...

Name: Z-1193-2012 PointCare NOW CD4NOW Gold Reagent Pack, or Gold Pack, Part Number :30034 In Vitro Diagnostic : Assay reagent...
Creator: Pointcare Technologies, Inc.
Published: 2011-11-02
License: https://open.fda.gov/license/

Pointcare Technologies, Inc. / initiated 2011-11-02 / Terminated / root cause: labeling and UDI

FDA source

Pointcare Technologies, Inc. began a recall of 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... on 2011-11-02. The reason FDA records is "Stability not assured at labeled temperature 2-42C". 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-1193-2012
Status: Terminated
Initiated: 2011-11-02
Posted: 2012-03-08
Terminated: 2012-04-26
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
Product code: GKZ Counter, Differential Cell
Reason for recall: Stability not assured at labeled temperature 2-42C
Root cause tag: labeling and UDI
FDA 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 [email protected] or call our offices directly at 1-508-281-6925.
Quantity in commerce: 463 packs
Distribution: International only: including countries of : Abuja, Haiti, Indonesia, Natal, Nigeria, Senegal, South Africa, Uganda, and United Kingdom.
Product codes and lots: Lot Numbers:KG13230, KG13231, KG21520 and KG21521

Product code GKZ

K072869Class IIPointcare Now SystemPointcare Technologies, Inc. / cleared 2008-01-14

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)