FDA Device recall Z-1212-2014
FreeStyle Flash Blood Glucose Monitors System
- FDA Device
- Class I
- terminated
- Published 2014-03-26
On 2014-03-26 the FDA classified a Class I recall of FreeStyle Flash Blood Glucose Monitors System by Abbott Diabetes Care, citing abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control soluti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1212-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-02-19 |
| Published | 2014-03-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Diabetes Care |
| Distribution | US |
Product
FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Meter can product inaccurate results. Intended to monitor blood glucose from samples taken from the body. IVD use only,
Reason
Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry.
Identifiers
| code_info | Catalog Number 17002 NDC 99073-0170-02. All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1212-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.