FDA Medical Device Recalls (openFDA)
Abbott Laboratories Inc.: Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20
- Recall number
- Z-0722-2007
- Recalling firm
- Abbott Laboratories Inc.
- Product
- Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20
- Status
- Terminated
- Initiated
- 2007-01-30
- Posted
- 2007-04-05
- Terminated
- 2011-08-10
- Reason
- Patient results are falsely decreased by up to 15% at these levels: 1) Serum Plasma phosphorus greater than 8.0 mg/dL (2.60 mmol/L) 2) Urine phosphorus greater than 80.0 mg/dL (25.80 mmol/L)
- Root cause
- Other
- Action
- A Product Correction letter dated January 30, 2007 provided to all Clinical Chemistry Phosphorus customers that have received lot numbers 42020HW00 and 44037HW00 stating that patient results are falsely decreased by up to 15% at these levels: Serum/Plasma phosphorus greater than 8.0 mgldL (2.60 mmol/L) and Urine phosphorus greater than 80.0 mg/dl. (25.80 mmol/L). Modified linearity ranges are provided in the letter that are to be implemented when using the two lots. Instructions are also provided for changing the linearity range on the Architect cSystem as well as the Aeroset System. Customers are instructed that If they have forwarded any of Information the Clinical Chemistry Phosphorus lots listed above to another laboratory to provide a copy of this letter to them. A customer response form is provided.
- Quantity
- 42020HW00 - 1,351 units worldwide; 44037HW00 - 314 units worldwide
- Distribution
- Worldwide, including USA, Canada, Trinidad & Tobago, Bahamas, Panama, Cayman Islands, Jamaica
- Lot, serial or model codes
- 42020HW00 & 44037HW00
- 510(k) numbers
- ["K981759"]
- PMA numbers
- not on file
- Product code
- CEO
- 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