FDA Device recall Z-2168-2017
AIA-PACK TPOAb CONTROL SET
- FDA Device
- Class III
- terminated
- Published 2017-06-07
On 2017-06-07 the FDA classified a Class III recall of AIA-PACK TPOAb CONTROL SET by Tosoh Bioscience, citing the label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (A….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2168-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-02-08 |
| Published | 2017-06-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tosoh Bioscience |
| Distribution | AK, FL, GA, MA, NY, OH, OK, TX |
Product
AIA-PACK TPOAb CONTROL SET
Reason
The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.
Identifiers
| code_info | TPOAb: G644783 Expires June 2017 & G844784 Expires August 2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2168-2017%22
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