FDA Medical Device Recalls (openFDA)
Abbott Ireland Diagnostics Division: Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
- Recall number
- Z-0666-2019
- Recalling firm
- Abbott Ireland Diagnostics Division
- Product
- Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
- Status
- Terminated
- Initiated
- 2018-11-21
- Posted
- not on file
- Terminated
- 2021-04-01
- Reason
- Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
- Root cause
- Nonconforming Material/Component
- Action
- The firm initiated the recall by letter on 11/21/2018. The notice explained the problem and provided instruction on how to inspect the reagent cartridges for defect. The consignee was directed to discard the defective units. The units will be replaced.
- Quantity
- 27 units
- Distribution
- AR, FL, GA, MD, OK, VA
- Lot, serial or model codes
- UDI/Lot Numbers (01)00380740160616 (17)190807(10)92056UI00 / 92056UI00
- 510(k) numbers
- ["K170317"]
- PMA numbers
- not on file
- Product code
- DHA
- Firm FEI
- 3005094123
- Firm city
- Lisnamuck Co. Longford
- Firm state
- not on file
- Firm country
- Ireland
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