Z-1206-03

Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube Catalog Number: NEA104 For in-vitro diagnostic use

Name: Z-1206-03 Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube Catalog Number: NEA104 For in-vitro diagnostic use
Creator: Perkinelmer Life Sciences, Inc.
Published: 2003-07-28
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2003-07-28 / Terminated / root cause: manufacturing process

FDA source

Perkinelmer Life Sciences, Inc. began a recall of Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube Catalog Number: NEA104 For in-vitro diagnostic use on 2003-07-28. The reason FDA records is "Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples". 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-1206-03
Status: Terminated
Initiated: 2003-07-28
Posted: 2003-09-12
Terminated: 2003-11-19
Recalling firm: Revvity Health Sciences, Inc.
Product: Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube Catalog Number: NEA104 For in-vitro diagnostic use
Product code: CIB Radioimmunoassay, Angiotensin I And Renin
Reason for recall: Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
Root cause tag: manufacturing process
FDA root cause: Other
Action: PerkinElmer notified all customers who received the lots by telephone by July 23, 2003 followed by letter dated July 25, 2003, which includes instructions for documenting receipt and lot removal either by destroying or returning product to PerkinElmer
Quantity in commerce: 29 Kits
Distribution: MD, NC, CA, VT, IL, MI, IL, NY, DC, MN, HI, WA, UT Nationwide. International: Belgium, Germany, Israel, UK, Canada, Hugary, Switzerland, Korea
Product codes and lots: Lot 181269, Expiration 8/27/03

Product code CIB

K850054Class IIRianen Angiotensin I Radioimmunoassay KiE.I. Dupont DE Nemours & Co., Inc. / cleared 1985-03-29

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)