Angiotensin I [125I] Radioimmunoassay Kit, 500 Tube Catalog Number: NEA105 For in-vitro diagnostic use
FDA Recall Z-1207-03 · Posted 2003-09-12
Advertisement
Recalling FirmPerkinelmer Life Sciences, Inc.
Recall StatusTerminated
Product CodeCIB
Date Initiated2003-07-28
Date Terminated2003-11-19
Product Quantity48 Kits
Reason for Recall
Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
Firm 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
Root Cause
Other
Distribution Pattern
MD, NC, CA, VT, IL, MI, IL, NY, DC, MN, HI, WA, UT Nationwide. International: Belgium, Germany, Israel, UK, Canada, Hugary, Switzerland, Korea
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement