Z-0573-2012

Heritage Labs Appraise DBS Bio Disk Test, Product K8304-QNS, each kit packed in a bag or envelope and...

Name: Z-0573-2012 Heritage Labs Appraise DBS Bio Disk Test, Product K8304-QNS, each kit packed in a bag or envelope and...
Creator: Heritage Labs International LLC
Published: 2011-01-09
License: https://open.fda.gov/license/

Heritage Labs International LLC / initiated 2011-01-09 / Terminated / root cause: manufacturing process

FDA source

Heritage Labs International LLC began a recall of Heritage Labs Appraise DBS Bio Disk Test, Product K8304-QNS, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No... on 2011-01-09. The reason FDA records is "Kits contain recalled Triad alcohol pads". 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-0573-2012
Status: Terminated
Initiated: 2011-01-09
Posted: 2012-01-11
Terminated: 2012-12-26
Recalling firm: Heritage Labs International LLC
Product: Heritage Labs Appraise DBS Bio Disk Test, Product K8304-QNS, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and instructions. Blood specimen collection
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: Kits contain recalled Triad alcohol pads
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis. Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads. Users are to use the replacement wipes instead of the wipes contained in the kits. For any questions call (888)764-4120.
Quantity in commerce: 100 kits
Distribution: Worldwide Distribution - USA (nationwide) and Germany
Product codes and lots: All kits containing Triad alcohol prep pads

Product code LCP

K990899Class IIHemochek-A1c Sample Collection KitOsborn Group, Inc. / cleared 1999-12-21

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)