FDA Medical Device Recalls (openFDA)
AMS Diagnostics, LLC: Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.
- Recall number
- Z-2725-2017
- Recalling firm
- AMS Diagnostics, LLC
- Product
- Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.
- Status
- Open, Classified
- Initiated
- 2016-02-29
- Posted
- not on file
- Terminated
- not on file
- Reason
- Lot was not functioning properly and not exhibiting the correct physical properties.
- Root cause
- Labeling mix-ups
- Action
- AMS Diagnostics contacted consignees by telephone on 02/29/2017. Representatives advised consignees to discard any recalled product on hand, to be replaced with working product. Customers should not return recalled product to the firm.
- Quantity
- 9 units
- Distribution
- US Nationwide Distribution in the states of AZ, CA, FL, MI, NC, NY, and SC.
- Lot, serial or model codes
- P/N 5409; Lot No. 15251; Exp. Date 09/2016
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JIX
- Firm FEI
- 3009128555
- Firm city
- Weston
- Firm state
- FL
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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