Z-0973-03

Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit, Catalog #FR-8050

Name: Z-0973-03 Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit, Catalog #FR-8050
Creator: PerkinElmer LIfe Sciences Inc
Published: 2002-05-16
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2002-05-16 / Terminated / root cause: manufacturing process

FDA source

PerkinElmer LIfe Sciences Inc began a recall of Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit, Catalog #FR-8050 on 2002-05-16. The reason FDA records is "The CSF Gels were manufactured incorrectly resulting in irregular wavy bands". 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-0973-03
Status: Terminated
Initiated: 2002-05-16
Posted: 2003-07-02
Terminated: 2008-10-24
Recalling firm: Revvity Health Sciences, Inc.
Product: Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit, Catalog #FR-8050.
Reason for recall: The CSF Gels were manufactured incorrectly resulting in irregular wavy bands.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm contacted the consignee by telephone on 5/16/2002.
Quantity in commerce: 10 kits
Distribution: The kits were shipped to one (1) consignee located in California.
Product codes and lots: Lot #204016, Exp 09 NOV 02

K843122Class IResolve-CsfIsolab, Inc. / cleared 1984-11-30

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)