FDA Medical Device Recalls (openFDA)
Perkinelmer Life Sciences, Inc.: Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube Catalog Number: NEA104 For in-vitro diagnostic use
- Recall number
- Z-1206-03
- Recalling firm
- Perkinelmer Life Sciences, Inc.
- Product
- Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube Catalog Number: NEA104 For in-vitro diagnostic use
- Status
- Terminated
- Initiated
- 2003-07-28
- Posted
- 2003-09-12
- Terminated
- 2003-11-19
- Reason
- Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
- 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
- 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
- Lot, serial or model codes
- Lot 181269, Expiration 8/27/03
- 510(k) numbers
- ["K850054"]
- PMA numbers
- not on file
- Product code
- CIB
- Firm FEI
- 1000513616
- Firm city
- Boston
- 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