FDA Medical Device Recalls (openFDA)
Abbott Laboratories Diagnostic Div: Clinical Chemistry Immunoglobulin M, List Number 1E01-20
- Recall number
- Z-0384-06
- Recalling firm
- Abbott Laboratories Diagnostic Div
- Product
- Clinical Chemistry Immunoglobulin M, List Number 1E01-20
- Status
- Terminated
- Initiated
- 2005-11-10
- Posted
- 2006-01-11
- Terminated
- 2007-03-20
- Reason
- These specific protein assays are not meeting the 57-day on board stability claim
- Root cause
- Other
- Action
- A Device Correction letter identifying the changes being made to the frequency of QC monitoring for these assays, will be distributed to all AEROSET and ARCHITECT c8000 customers which utilize the IgM, Prealbumin and Apolipoprotein Al Specifc Protein assays on November 10,2005 via direct mailing. Outside the U.S. each country organization will need to determine the appropriate method for the effectiveness check..
- Quantity
- 1275 (212 in US)
- Distribution
- Nationwide, plus Australia, Canada, Columbia, Germany, Guatemala, Hong Kong, mexico, & New Zealand
- Lot, serial or model codes
- Lot Number(s): 30067HW00, 27057HW00, & 23026HW00
- 510(k) numbers
- ["K983132"]
- PMA numbers
- not on file
- Product code
- DFT
- Firm FEI
- 2018433
- Firm city
- South Pasadena
- Firm state
- CA
- 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
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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