FDA Medical Device Recalls (openFDA)
Abbott Diagnostic International, Ltd.: Architect AUSAB Calibrators IVD - list number 1L82-01 has six (6) bottles with the following companents: 1) Calibrator A and 2) Calibrators B thru F. in vitro diagnostic.
- Recall number
- Z-1097-2007
- Recalling firm
- Abbott Diagnostic International, Ltd.
- Product
- Architect AUSAB Calibrators IVD - list number 1L82-01 has six (6) bottles with the following companents: 1) Calibrator A and 2) Calibrators B thru F. in vitro diagnostic.
- Status
- Terminated
- Initiated
- 2007-05-14
- Posted
- 2007-07-24
- Terminated
- 2011-06-10
- Reason
- During an internal study, the Architect AUSAB assay was found to read preparations of the WHO standard up to 53% higher than the WHO assigned value. This has the potential to cause elevated results and may impact the interpretation for a small percentage of results with grayzone or low-level reactive concentrations and higher proficiency sample results.
- Root cause
- Other
- Action
- All ARCHITECT AUSAB U.S. customers will be contacted. New customers will be contacted through a Product Information Letter that will be included in all ARCHITECT AUSAB Reagent Kits until assay is restandardized. All ARCHITECT AUSAB U.S. customers will be contacted. The following communication types were used: Product Correction Letter Customer Reply Form > Product Information Letter to be included in new kits to be distributed. Letters were sent to customers by Federal Express Priority mail. The Customers were instructed to: Please follow their laboratory procedures for evaluation of these results Disregard the automated interpretation of results for low-level reactive samples. A customer reply form will accompany the Product Correction letter. Effectiveness Check Depth: 100% of customers receiving the Product Correction letter. The start date of communication was May 14,2007.
- Quantity
- 247
- Distribution
- Nationwide and Puerto Rico
- Lot, serial or model codes
- LIST # 01L82-01 Lots # 50337Q100 Exp Date 08/21/2007, 48265Q100 Exp Date 06/13/2007, 45555Q100 Exp Date 03/14/2007, 44594Q100 Exp date 02/28/2007, and 42585Q100 Exp Date 01/01/2007
- 510(k) numbers
- not on file
- PMA numbers
- ["P050051"]
- Product code
- LOM
- Firm FEI
- 2623532
- Firm city
- Barceloneta
- Firm state
- PR
- 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