International safety notice
Due to the occurrence of cracks in the parts (pump housing) incorporated in certain serial numbers of the product, our company Affinion HbA1c, Affinion ACR, and Affinion Lipid, which are separately manufactured and sold by Error code 214 or 215 when measuring head panel, or error code 3 when measuring affinion CRP. 02 occurs frequently, so we are conducting a recall.
Japan / PMDA Recalls · JPN · Jun 28, 2024
Key facts
| Title | Due to the occurrence of cracks in the parts (pump housing) incorporated in certain serial numbers of the product, our company Affinion HbA1c, Affinion ACR, and Affinion Lipid, which are separately manufactured and sold by Error code 214 or 215 when measuring head panel, or error code 3 when measuring affinion CRP. 02 occurs frequently, so we are conducting a recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Pack-type clinical chemistry analyzer Sales name: Affinion 2 |
| Manufacturer | Abbott Diagnostics Medical Co., Ltd. |
| Models | AF20059483, AF20055852, AF20055545, AF20058272, AF20052954, AF20053701, AF20057613, AF20058954, AF20059210, AF20059465, AF20059524, AF20057529 and 189 more |
| Date | Jun 28, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1